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Seedling Enterprises
:: Announcements and Press Releases
:: Seedling Management |
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Announcements and Press Releases August 30, 2011 July,
2011 There has been continued favorable news from GI Dynamics and Pioneer Surgical regarding the Seedling companies. For further information, please review their respective websites. In summary: In addition, EndoBarrier® Gastrointestinal Liner System was highlighted during Digestive Disease Week® (DDW) 2011, May 7-10, in Chicago. Results were presented from a clinical study conducted by E.G.H.D. Moura, M.D., Ph.D., director of endoscopy, Hospital das Clinicas, University of São Paulo, São Paulo, Brazil.. These previously reported data showed that 12 months of treatment with the EndoBarrier promoted significant improvements in blood sugar control, weight loss and key cardiovascular risk factors. GI Dynamics was also notified of issuance of two additional patents. Patent number 7,837,643 describes methods and systems for delivering or placing a gastrointestinal implant device into a mammal. Patent number 7,935,073 describes a method and apparatus for limiting absorption of food products in specific parts of the digestive system is presented. GI Dynamics has received European CE mark approval for the EndoBarrier, a non-surgical therapy to treat type 2 diabetes and obesity. This approval is specific to up to 12 months of treatment with the EndoBarrier; the product has already received CE mark approval for three and six months of treatment. Through its commercial partner, Elemental Healthcare, GI Dynamics has also announced the launch of the EndoBarrier in the United Kingdom. In addition, to favourable sales of bone graft materials, Pioneer has several products in its development pipeline that will expand the clinical offering for nanOss products. These products are intended for release during 2011. The Biologics Division of Pioneer Surgical has announced the United States Patent Office has reissued RE41,584 a patent further strengthening Pioneer's market position in nanocrystalline derived products used in orthopaedics. The patent supports Pioneer Surgical's nanocrystalline calcium phosphate technology – nanOss™. In addition, patent number 7,947,759 issued which discloses cement products, methods of forming cement using the cement product, and methods of using the cement product in orthopedic and dental applications. December,
2010
The
following provides a
brief description of the current situation at each of the Seedling
Enterprises
start up companies. For further information, please review
the GIDynamics
and Pioneer Surgical Technologies websites.
November,
2010 Pioneer has also informed Seedling that significant progress has been made in the NanOs cement development program. Completion of a regulatory submission and clearance are important milestones that provide additional distributions of Pioneer stock to Seedling members. November, 2010
November, 2010 “Forums like the Medical Innovation Summit provide an opportunity to engage, educate and learn about existing best practices and new treatment approaches that will help improve and manage these twin epidemics, and shape the future of patient care,” said Mr. Randle. “I am pleased to be part of this forum, and appreciate the opportunity to contribute our thinking and insights gleaned from our efforts to develop the EndoBarrier, a non-surgical therapeutic for the treatment of type 2 diabetes and obesity.” Mr. Randle will participate in a panel, “The Revolution in Diabetes Treatment, Surgical Intervention & Novel Therapies Explored,” on November 3, 2010 at 9:10 a.m. (EDT). Panelists will discuss forthcoming diabetes disease management and therapeutic treatment options, including GI Dynamics’ EndoBarrier Gastrointestinal Liner.
October, 2010 Innovative Medical Device Offers Patients
a Catalyst for Regaining Control of Diabetes and Weight; Targeted
Rollout Begins with Centers of Excellence Alberic Fiennes, M.D., consultant bariatric surgeon at St. Anthony's Hospital in Surrey, said: “This new procedure is pioneering in that it works as a metabolic regulator directly treating type 2 diabetes and associated weight-gain, giving patients a chance to drastically improve their condition. I was excited when I first heard about EndoBarrier and impressed at the results produced by clinical studies that showed that as early as the first week post procedure, patients can experience a significant effect on their diabetes.” Clinical trials involving more than 300 patients have demonstrated the significant weight loss and diabetes improvement achieved with the EndoBarrier Gastrointestinal Liner. In fact, the EndoBarrier has been clinically proven to lower HbA1c levels (data presented at Digestive Disease Week 2010) and achieve weight loss of more than 20.0 percent of total body weight during 12 months of treatment (data presented at the International Federation for Surgery of Obesity and Metabolic Disorders 2010 World Congress, and Obesity 2010: 28th Annual Scientific Meeting of The Obesity Society). The EndoBarrier procedure is quick, incisionless and reversible, and many patients often go home the day of the procedure. In recent clinical trials, there have been no serious adverse events and the most common potential side effects include pain, nausea and vomiting, which generally resolves in the first two weeks of treatment. The EndoBarrier is suitable for patients who have type 2 diabetes with a BMI of 30 to 50. It is initially being offered to private patients at St Anthony’s Hospital in Surrey and is hoped to become available on the National Health Service in due course, following trials at three NHS hospitals that have been designated Centers of Excellence: Imperial College St. Mary’s Hospital, Southampton University Hospital and Trafford General Hospital, Manchester. People living in the U.K. and interested in learning more about taking part in one of the NHS trials can email patients@EBstudy.co.uk or call freephone 0800 096 2418. “We believe the EndoBarrier, as part of a multidisciplinary approach, has the potential to change the treatment paradigm for type 2 diabetes and weight problems,” stated Julian Teare, M.D., FRCP, consultant gastroenterologist, Imperial College, London, and principal investigator of the NHS trial. “Based on the data to-date and its unique profile as a non-surgical and non-pharmaceutical treatment option, the EndoBarrier appears to provide many of the benefits of gastric bypass surgery through an endoscopic approach. We are delighted to be among the first in Europe to have access to the EndoBarrier as a new treatment option in our fight against these epidemics.” With the EndoBarrier, GI Dynamics is defining a new class of metabolic treatment options that fit between pharmaceutical regimens and surgery, called non-surgical therapeutics. Non-surgical therapeutics are designed to eliminate or reduce the risks and side effects associated with pharmaceutical regimens as well as surgical options. This new class of treatment can be performed easily and quickly without any incisions, thus reducing patient anxiety and recuperative time. Additionally, non-surgical therapeutics hold the potential to improve the patient’s overall health, by providing the control necessary to institute lifestyle and nutritional improvements to maintain therapeutic effect, while being easily removed once the desired effect has been attained and lifestyle changes implemented. “This European approval for 12 months of EndoBarrier therapy to treat type 2 diabetes and obesity is another key milestone for GI Dynamics as we launch the product in the U.K.,” stated Stuart A. Randle, chief executive officer of GI Dynamics. “The data presented last month at IFSO demonstrate the significant potential for EndoBarrier to offer a much needed alternative to traditional interventions such as pharmaceutical treatments and surgery. We look forward to training additional centers in Europe over the next year and making the EndoBarrier available more broadly in the near future.
September, 2010 Obese Patients Achieved Mean Weight Loss
of 20%; Data Presented at IFSO 2010 World Congress “We now have data demonstrating the safety and efficacy of 12 months of EndoBarrier therapy in clinically obese patients and the impact this treatment approach has on related health issues such as hypertension, dyslipidemia and metabolic syndrome,” commented Alex Escalona, M.D., Department of Digestive Surgery, Pontificia Universidad Católica de Chile, Santiago, Chile, member of GI Dynamics’ scientific advisory board and lead investigator of the study. “We have previously reported notable HbA1c results achieved in patients with type 2 diabetes after nine months of treatment, and now a subset of our 12-month data in obese patients with type 2 diabetes reinforces the significant opportunity for EndoBarrier to provide a new, non-surgical solution for the treatment of type 2 diabetes.” These data were presented in an oral presentation this week at the International Federation for Surgery of Obesity and Metabolic Disorders (IFSO) 2010 World Congress in Los Angeles, Calif. The clinical trial was designed to examine the safety and efficacy of the EndoBarrier in obese patients over 12 months. Twenty-four obese patients with an average weight of 110.7 kg and average body mass index (BMI) of 45.3 were successfully implanted with the EndoBarrier. The patients also exhibited baseline co-morbidities including type 2 diabetes, hypertension, dyslipidemia and metabolic syndrome. At 12 months of treatment with the EndoBarrier, patients achieved: * Mean absolute weight loss of 22.5 kg (49.5 lbs),
or 20.0% (p = <0.0001) Patients also experienced the following improvements in key cardiovascular risk factors: * Reduction in total cholesterol levels from 196.5
mg/dL at baseline to 161.0 mg/dL (p = <0.0001) Notably, data from a subset of six patients with type 2 diabetes with mean baseline HbA1c of 7.9% showed that patients achieved a mean reduction in HbA1c of 1.4 (p=0.05) following 12 months of treatment with the EndoBarrier. “At a time when physicians are seeking alternatives to pharmaceutical and surgical interventions for obesity and type 2 diabetes, these 12-month data are further support for the market potential of EndoBarrier and pave the way for our upcoming launch of EndoBarrier in Europe this fall,” said Stuart A. Randle, chief executive officer of GI Dynamics. “We believe that our breakthrough non-surgical therapeutic has the potential to change the treatment paradigm for obese patients who want to regain control of their type 2 diabetes while also potentially improving other factors associated with these conditions.” In addition, EndoBarrier data was highlighted at IFSO in the Latin American Course by Dr. Escalona and the “Innovations in Endoluminal Procedures” session by Jan Willem Greve, M.D., Ph.D., Gastrointestinal and Bariatric Surgery, Atrium Medical Center Parkstad, Heerlen, Netherlands and member of GI Dynamics’ scientific advisory board, which took place on Saturday, September 4, 2010.
September, 2010 “GI Dynamics is very pleased to establish this partnership with Elemental Healthcare, a premier medical device distribution organization in the U.K.,” stated Stuart A. Randle, chief executive officer of GI Dynamics. “Elemental Healthcare’s proven sales track record, and experience in the diabetes and obesity markets and with bringing minimally invasive products to healthcare providers and surgeons, will be invaluable as the EndoBarrier becomes commercially available in select markets later this year.” In preparation for the European launch of the EndoBarrier, GI Dynamics and Elemental Healthcare are identifying, training and designating Centers of Excellence and expanding clinical experience with the EndoBarrier. The Centers of Excellence participating in this effort in the U.K. include St. Anthony’s Hospital, Imperial College/St. Mary’s Hospital, National Obesity Surgery Center (Manchester) and Southampton University Hospital. Designated Centers of Excellence will have exclusive access over the next several months to the EndoBarrier as a cornerstone of an overall patient care program to treat patients with type 2 diabetes and obesity. Adam Power, managing director, Elemental Healthcare commented, “The epidemic of type 2 diabetes and obesity is an issue that cannot afford to be ignored and EndoBarrier addresses both of these concerns. We are excited about our partnership with GI Dynamics and proud that we can now offer U.K. and Northern Ireland-based physicians the most advanced non-surgical technology available on the market.” About Elemental Healthcare
August, 2010 “We are pleased to welcome Wade and Karl to the GI Dynamics team as we prepare for the European launch of EndoBarrier,” stated Stuart A. Randle, chief executive officer of GI Dynamics. “This is a very exciting time for GI Dynamics. We are confident that Wade’s expertise in marketing medical devices in global markets, and Karl’s experience successfully launching innovative technologies in Europe, will add substantial value to our team and further strengthen the commercialization efforts in support of the EndoBarrier launch.” Mr. Fox joins GI Dynamics from Covidien and brings more than 20 years of medical device marketing experience in all aspects of company development, strategic planning and marketing, customer and physician network building and account development, as well as company and product branding and positioning. Most recently at Covidien, he served as global director of strategic marketing, biologics and tissue repair, where he trained the sales force in product repositioning and implemented a global go-to-market strategy. Prior to his role at Covidien, Mr. Fox held various marketing positions with Tissuescience Inc., Diomed Inc., Abiomed Inc, Smith and Nephew, Endoscopy Division and Baxter International. Mr. Fox received an M.B.A in finance and marketing from Wake Forest University. “With obesity and type 2 diabetes reaching epidemic proportions around the globe, there is significant opportunity for new and innovative technologies to help patients gain control over their diabetes while also achieving clinically meaningful weight loss,” said Mr. Fox. “EndoBarrier represents an innovative approach in the way these conditions are treated. I am thrilled to join the GI Dynamics team at such an exciting time in the company’s growth and look forward to further expanding our efforts globally as we prepare for the European launch of EndoBarrier.” Dr. Blohm is a seasoned strategic commercial executive and general manager with more than 20 years of medical device industry experience, combining capital equipment and medical devices in large company and small company environments. Prior to joining GI Dynamics, Dr. Blohm served as partner and general manager of AB Medica, a national medical technology distribution company he established in France. Prior to AB Medica, Dr. Blohm played a key role in leading the successful launches of innovative medical devices and technologies in his previous positions at EndoGastric Solutions, Accuray Europe and Siemens. He received a Ph.D. in physics from the University of Paris. “GI Dynamics is poised to revolutionize the treatment of obesity and type 2 diabetes with its innovative, non-surgical, non-pharmaceutical EndoBarrier technology,” commented Dr. Blohm. “EndoBarrier represents a significant advance in treating both type 2 diabetes and obesity – conditions which dramatically impact the lives of millions of patients worldwide. The clinical results achieved to date are impressive, and I look forward to introducing this unique and innovative therapeutic approach to clinicians and patients in Europe this fall.” Media Contact:
May, 2010 Data from Clinical Studies Presented at
Digestive Disease Week Stuart A. Randle, chief executive officer of GI Dynamics, stated, “GI Dynamics is preparing to commercialize the EndoBarrier in Europe, and we are committed to delivering a solution for patients combating type 2 diabetes and weight gain. We recognize that patients living with diabetes and the physicians who treat them are looking for safe and effective alternatives to traditional pharmaceutical and surgical therapies, and we believe these new data underscore the significant opportunity for our innovative approach in addressing these serious metabolic conditions.” The EndoBarrier was implanted in 61 patients in two prospective, single arm studies at two institutions in Brazil and Chile. One study enrolled 39 patients who were obese with a mean BMI of 43.8 ± 0.9 kg/m2 (range: 35.4-58.2 kg/m2) while a second study enrolled 22 patients who were obese with a mean BMI of 44.9 ± 1.6 kg/m2 (range: 35.6-59.6 kg/m2) and with type 2 diabetes. These patients had a mean baseline HbA1c of 8.9 ± 0.4% (range: 6.7-11.6%). Assessments in both trials were similar and included monthly weights and safety evaluations. The diabetes trial also assessed blood sugar levels (HbA1c) at all post-implant follow-up visits. The mean change in weight at 24 weeks (n=48) was -15.0±1.1kg (-27.0±1.7% excess weight; -13.1±0.9% total body weight). In the diabetes study at week 24 (n=16), the change in HbA1c was -1.5±0.4% while 58% of the subjects (7/12 with data) achieved HbA1c of 7% or less. There was one migration of the EndoBarrier prior to 24 weeks (1.6%), a significant improvement (p< 0.05) over the first generation design (31%). There were an additional eight early removals due to device-related adverse events such as GI discomfort. All implants were delivered and removed endoscopically with the implant procedures taking less than 30 minutes and removal procedures taking less than 15 minutes. “These data are based on our second-generation EndoBarrier which was designed for a longer duration of therapy. Subsequent to the successful completion of the trials evaluating EndoBarrier treatment for 6 months, we have successfully completed a clinical trial evaluating the EndoBarrier for 12 months with impressive results in both weight loss and glycemic improvement,” stated Andy Levine, founder and chief technology officer of GI Dynamics. “Based on the consistent and enhanced results we have seen at 12 months, we plan to pursue commercialization and additional clinical development for this longer treatment period, and we look forward to sharing the results from 12 months of EndoBarrier treatment at IFSO later this year.” Addressing Unmet Need for Treating Type 2 Diabetes
and Obesity
March, 2010 The average baseline weight for the subjects was 270.5 lbs (± 22.2 1bs), average baseline HbA1c was 9.3% (± 0.8%) and subjects were taking oral anti-diabetes medications. Top-line results for the first six subjects show that on average patients achieved the following results: * HbA1c decrease of 2.5% (± 0.6%) with 5 of the 6
getting below 7.0%
February, 2010 Trial is Currently Enrolling Patients at
Three Investigational Sites in the Netherlands “In addition to facilitating weight loss, data from clinical trials conducted to date have shown that the EndoBarrier lowers HbA1c levels and helps control diabetic factors in obese patients with type 2 diabetes, results similar to those experienced with gastric bypass surgery,” stated Dr. Greve. “Following the recent European CE mark approval for the EndoBarrier and the initiation of this clinical trial, we look forward to further exploring the therapeutic potential of the EndoBarrier as a non-surgical and non-pharmaceutical treatment option for the millions of patients suffering from the twin epidemics of type 2 diabetes and obesity.” The trial is an open label, randomized, controlled study which will enroll approximately 70 patients with type 2 diabetes among the three investigational sites. Trial participants will be randomized one to one with 35 patients receiving EndoBarrier treatment and 35 patients in the diet control group. The trial lasts for 12 months and evaluates reduction in HbA1c and weight loss. Patients in the diet control group may be offered to receive EndoBarrier treatment after 12 months participating in the trial. The trial is currently recruiting male and female patients between the ages of 18 to 65 years with type 2 diabetes who have been treated for their type 2 diabetes for 1 to ?10 years, have a body mass index (BMI) between 30 and 50, and HbA1c level >7.5 and ?10.0%. For more information on the trial, including detailed inclusion and exclusion criteria, please visit www.clinicaltrials.gov or contact the clinical trial call center at 043 - 308 81 50 or EndoBarrier@meditech.nl. Addressing Unmet Need for Treating Type 2 Diabetes The EndoBarrier, a non-surgical therapy to treat type 2 diabetes and obesity, received European CE mark approval in December 2009. Clinical trials to date involving more than 280 patients have demonstrated the significant weight loss and diabetes improvement with the EndoBarrier Gastrointestinal Liner. Type 2 diabetes affects an estimated 21 million Americans and 200 million people worldwide. According to the World Health Organization, type 2 diabetes comprises 90% of people with diabetes around the world, and is largely the result of excess body weight. Type 2 diabetes can lead to significant health problems including cardiovascular disease, retinopathy, neuropathy and nephropathy. GI Dynamics is defining a new class of metabolic treatment options that fit between pharmaceutical regimens and surgery, called non-surgical therapeutics. Non-surgical therapeutics are designed to eliminate or reduce the risks and side effects associated with pharmaceutical regimens as well as surgical options. This new class of treatment can be performed easily and quickly without any incisions, thus reducing patient anxiety and recuperative time. Unlike traditional pharmaceutical approaches, non-surgical therapeutics remove the burden of dose regimen compliance from the patient. Additionally, non-surgical therapeutics hold the potential to improve the patient’s overall health, by providing the control necessary to institute lifestyle and nutritional improvements to maintain therapeutic effect, while being easily removed once the desired effect has been attained and lifestyle changes implemented. Media Contact:
February, 2010 “I look forward to presenting clinical study information for the EndoBarrier, a compelling, emerging endoscopic technology, to my colleagues in the endoscopy and bariatric surgery fields during NOTES Day at the Surgery of the Foregut Symposium,” commented Dr. Escalona. “This symposium provides an excellent opportunity to share my own clinical experience with the EndoBarrier, as well as additional safety and efficacy data from clinical trials conducted to date, as a promising non-surgical treatment option for patients suffering from type 2 diabetes and obesity.” Dr. Escalona will highlight EndoBarrier weight loss data in a presentation, entitled “Endoscopic duodenal-jejunal bypass: principles and results in obesity,” at 11:10 a.m. EST and additional EndoBarrier type 2 diabetes data in a presentation, entitled “Endoscopic duodenal-jejunal bypass: results in type 2 diabetes,” at 11:30 a.m. EST on Sunday, February 14, 2010. “The incidence of type 2 diabetes and obesity continue to rise at alarming rates across the globe and innovative solutions are clearly needed,” stated Stuart A. Randle, chief executive officer of GI Dynamics. “With experience in more than 280 patients to-date, a growing body of clinical evidence demonstrates that the EndoBarrier provides a novel, non-surgical approach to treating these diseases – simultaneously improving diabetic factors in patients with type 2 diabetes and facilitating significant weight loss in obese patients. We appreciate the continued support of Dr. Escalona, and the rest of our clinical investigators and their patients, as we continue our development effort and prepare to bring the EndoBarrier to market.” Addressing Unmet Need for Treating Type 2 Diabetes and Obesity The EndoBarrier, a non-surgical therapy to treat type 2 diabetes and obesity, received European CE mark approval for the treatment of type 2 diabetes and obesity in December 2009. Clinical trials to date involving more than 280 patients have demonstrated the significant weight loss and diabetes improvement achieved with the EndoBarrier Gastrointestinal Liner. Type 2 diabetes affects an estimated 21 million Americans and 200 million people worldwide. According to the World Health Organization, type 2 diabetes comprises 90% of people with diabetes around the world, and is largely the result of excess body weight. Type 2 diabetes can lead to significant health problems including cardiovascular disease, retinopathy, neuropathy and nephropathy. GI Dynamics is defining a new class of metabolic treatment options that fit between pharmaceutical regimens and surgery, called non-surgical therapeutics. Non-surgical therapeutics are designed to eliminate or reduce the risks and side effects associated with pharmaceutical regimens as well as surgical options. This new class of treatment can be performed easily and quickly without any incisions, thus reducing patient anxiety and recuperative time. Unlike traditional pharmaceutical approaches, non-surgical therapeutics remove the burden of dose regimen compliance from the patient. Additionally, non-surgical therapeutics hold the potential to improve the patient’s overall health, by providing the control necessary to institute lifestyle and nutritional improvements to maintain therapeutic effect, while being easily removed once the desired effect has been attained and lifestyle changes implemented. Media Contact:
January, 2010
December, 2009
Aug. 26, 2009 12:30 UTC EndoBarrier ™ Gastrointestinal Liner Plus EndoBarrier Flow Restrictor Dramatically Increases Weight Loss in Obese Patients; Compelling Impact on Diabetes Risk Factors PARIS--(BUSINESS WIRE)-- GI Dynamics, a leader in non-surgical treatments for type 2 diabetes and obesity, today announced that additional results from a previously reported clinical study regarding mechanisms of action will be presented on Saturday, August 29, 2009 by Manoel Galvao Neto, M.D., scientific coordinator, Gastro Obeso Center, Sao Paulo, Brazil and lead investigator for the study, at the International Federation for the Surgery of Obesity and Metabolic Disorders (IFSO) 14th World Congress in Paris, France. This study, previously highlighted in June at the 26th annual meeting of the American Society for Metabolic and Bariatric Surgery (ASMBS), demonstrated the substantially enhanced weight loss benefits of combining the company’s EndoBarrier Gastrointestinal Liner with a new EndoBarrier Flow Restrictor. The EndoBarrier Flow Restrictor provides an adjustable restriction at the outlet of the stomach and is designed to delay gastric emptying (GE), an additional mechanism which adds to the therapeutic effects of the liner. The GE data being reported at IFSO support this novel mechanism. “We have had significant clinical experience with the EndoBarrier at our obesity management center, and even when assessed relative to invasive and other noninvasive procedures, we believe the EndoBarrier platform represents a much needed new approach to reducing weight and improving blood sugar control in obese patients and patients at risk for serious metabolic disease,” stated Dr. Galvao. “In particular, we are excited about the new data emerging from our ongoing clinical study in people living with type 2 diabetes and the notable impact EndoBarrier appears to have on blood sugar control. We look forward to sharing these data later this year upon completion of the trial.” Stuart A. Randle, chief executive officer of GI Dynamics commented, “We are seeing the clear need and desire for a non-surgical approach to treating type 2 diabetes while simultaneously addressing weight problems, especially in patients with consistently difficult to manage blood sugar levels. Our growing clinical experience with EndoBarrier suggests that this product and our platform are uniquely suited to meet these challenges and provide a completely new way of addressing the twin epidemics of type 2 diabetes and obesity.” GI Dynamics is defining a new class of metabolic treatment options that fit between pharmaceutical regimens and surgery, called non-surgical therapeutics. Non-surgical therapeutics are designed to eliminate or reduce the risks and side effects associated with pharmaceutical regimens as well as surgical options. This new class of treatment can be performed easily and quickly without any incisions, thus reducing patient anxiety and recuperative time. Unlike traditional pharmaceutical approaches, non-surgical therapeutics remove the burden of dose regimen compliance from the patient. Additionally, non-surgical therapeutics hold the potential to improve the patient’s overall health, by providing the control necessary to institute lifestyle and nutritional improvements to maintain therapeutic effect, while being easily removed once the desired effect has been attained and lifestyle changes implemented. Clinical trials involving more than 250 patients have demonstrated the dramatic weight loss and diabetes improvement achieved with the EndoBarrier Gastrointestinal Liner.
View this news release online at:
August, 2009 LumeRx has announced that effective immediately
that all operation will cease. The management has left the company and
remaining business transactions associated with the closure are being
handled by Josh Tolkoff. The equipment and any other assets will be sold to pay off the remaining legal and accounting bills. Please contact Josh Tolkoff if you have any questions. Josh Tolkoff
June 26, 2009 13:20 UTC EndoBarrier ™ Gastrointestinal Liner Plus Flow Restrictor Facilitates Substantial Excess Weight Loss; Median %EWL of 39.6 Percent LEXINGTON, Mass.--(BUSINESS WIRE)-- GI Dynamics, a leader in non-surgical treatments for type 2 diabetes and obesity, today announced results from a pilot clinical study which demonstrated the substantially enhanced weight loss effects of combining the company’s EndoBarrier Gastrointestinal Liner with a new EndoBarrier Flow Restrictor. The EndoBarrier Flow Restrictor provides an adjustable restriction at the outlet of the stomach and is designed to delay gastric emptying, an additional mechanism which adds to the therapeutic effects of the liner. The results were presented today at the 26th annual meeting of the American Society for Metabolic and Bariatric Surgery (ASMBS). In this initial, single-center study of 10 morbidly obese people (body mass index between 35.8 and 47.8), participants achieved the following results over a twelve-week period during which the device was implanted (median values reported): * Percent Excess Weight Loss (%EWL): 39.6% All 10 patients completed the 12-week study. The most common side effects included mild to moderate abdominal pain, nausea and vomiting. “These results are unparalleled for a non-surgical treatment for obesity,” stated Alex Escalona, M.D., Department of Digestive Surgery, Pontificia Universidad Católica de Chile, Santiago, Chile and lead investigator for the pilot study. “Like the United States, Chile is struggling with a growing epidemic of obesity and related metabolic disorders and life-threatening conditions. Traditionally, non-surgical treatment approaches have proven insufficient for the morbidly obese, but these data suggest we may have an effective new option to offer these patients. Based on the excellent results I observed in this pilot study, I believe the combination device may offer hope for patients battling significant weight loss needs and associated co-morbidities, and clearly deserves further study in longer-term, controlled clinical trials.” Clinical trials involving more than 250 patients have demonstrated the dramatic weight loss and diabetes improvement achieved with the EndoBarrier Gastrointestinal Liner. These latest data suggest that the combination of the EndoBarrier Gastrointestinal Liner with the EndoBarrier Flow Restrictor could enhance the effectiveness of the liner by nearly doubling the amount of weight loss achieved by using the liner alone. These clinical data are consistent with recently reported preclinical data assessing the combination of devices in a porcine model. The preclinical data were featured at the Society of American Gastrointestinal and Endoscopic Surgeons 2009 Annual Meeting in April. “We are very pleased with the results seen in this pilot study and the increased effect on weight loss achieved by the combination of the EndoBarrier Gastrointestinal Liner with the EndoBarrier Flow Restrictor,” said Stuart A. Randle, chief executive officer of GI Dynamics. “We believe that the combination of these devices impacts weight loss through distinct mechanisms of action and may truly represent a breakthrough in non-surgical treatment of type 2 diabetes and obesity. GI Dynamics is conducting ongoing clinical studies investigating the synergistic effects of the combined devices. Our platform is well positioned to deliver a portfolio of devices that will allow physicians to choose the most appropriate non-surgical therapy for each patient’s individual weight loss goals and glycemic control needs.” GI Dynamics is defining a new class of metabolic treatment options that fit between pharmaceutical regimens and surgery, called non-surgical therapeutics. Non-surgical therapeutics are designed to eliminate or reduce the risks and side effects associated with pharmaceutical regimens as well as surgical options. This new class of treatment can be performed easily and quickly without any incisions, thus reducing patient anxiety and recuperative time. Unlike traditional pharmaceutical approaches, non-surgical therapeutics remove the burden of dose regimen compliance from the patient. Additionally, non-surgical therapeutics hold the potential to improve the patient’s overall health, by providing the control necessary to institute lifestyle and nutritional improvements to maintain therapeutic effect, while being easily removed once the desired effect has been attained and lifestyle changes implemented.
June 18, 2009 - New Clinical Data on GI Dynamics’ EndoBarrier™ Flow Restrictor to be Presented at the 26th Annual Meeting of the American Society for Metabolic and Bariatric Surgery Company will also Exhibit at ASMBS; Booth #1017 LEXINGTON, Mass.--(BUSINESS WIRE)-- GI Dynamics, a leader in non-surgical treatments for type 2 diabetes and obesity, today announced that results from a pilot clinical study of the company’s EndoBarrier Gastrointestinal Liner in combination with a new EndoBarrier Flow Restrictor in morbidly obese patients will be presented at the 26th Annual Meeting of the American Society for Metabolic and Bariatric Surgery (ASMBS) in Grapevine, Texas. The presentation, entitled “Initial human experience with a restrictive, duodenal-jejunal bypass liner for the treatment of morbid obesity,” will be delivered by Alex Escalona, M.D., Department of Digestive Surgery, Pontificia Universidad Católica de Chile, Santiago, Chile and lead investigator for the pilot study, during the Emerging Technologies/Basic Research Session in the Medical Specialties Track of ASMBS, on Friday, June 26 at 8:20 a.m. (CDT). These data represent the first clinical data for the newly developed EndoBarrier Flow Restrictor combined with the EndoBarrier Gastrointestinal Liner. The EndoBarrier Flow Restrictor provides an adjustable restriction at the outlet of the stomach and is designed to delay gastric emptying, an additional mechanism which adds to the therapeutic effects of the liner. “GI Dynamics is pioneering a new class of metabolic treatment options that fit between pharmaceutical regimens and surgery, called non-surgical therapeutics. Non-surgical therapeutics are designed to eliminate or reduce the risks and side effects associated with pharmaceutical regimens as well as surgical options,” stated Stuart A. Randle, chief executive officer of GI Dynamics. “Clinical trials involving more than 250 patients have demonstrated the dramatic weight loss and diabetes improvement achieved with the EndoBarrier Gastrointestinal Liner, and earlier this year compelling preclinical weight loss data for the EndoBarrier Flow Restrictor and liner combination were presented at SAGES. These new clinical data add to the growing body of data that show our EndoBarrier platform is a promising new therapeutic approach to treat patients with both type 2 diabetes and obesity.” The preclinical study presented at SAGES was designed to assess the effects on body weight in a porcine model of the EndoBarrier Flow Restrictor alone and in combination with the EndoBarrier Gastrointestinal Liner. Preclinical findings demonstrated that treatment with the EndoBarrier Flow Restrictor limits weight gain in growing pigs to a similar degree as the EndoBarrier Gastrointestinal Liner, but when combined, both the liner and the flow restrictor resulted in approximately twice the effect of decreased weight gain compared to either treatment alone. For more information on GI Dynamics and the EndoBarrier, please visit booth #1017 during ASMBS. View this news release online at:
June 3, 2009 - GI Dynamics’ EndoBarrier™ Gastrointestinal Liner to be Highlighted at Several Prominent International Diabetes and Obesity Meetings LEXINGTON, Mass.--(BUSINESS WIRE)-- GI Dynamics, a leader in non-surgical, endoscopic approaches for the treatment of type 2 diabetes and obesity, today announced that its EndoBarrier Gastrointestinal Liner will be highlighted by leading experts in metabolic disorders and endoscopy at several international diabetes and obesity meetings. “This is proving to be a very successful year for GI Dynamics and our development efforts in support of the EndoBarrier,” said Stuart A. Randle, chief executive officer of GI Dynamics. “Based on the data we have seen to date, we believe EndoBarrier, as part of a multidisciplinary approach, has the potential to dramatically change the treatment paradigm for type 2 diabetes and weight problems due to its unique profile as a non-surgical and non-pharmaceutical treatment option. Notably, EndoBarrier may provide the benefits of gastric bypass surgery without the complications and risks associated with a highly invasive procedure, and unlike traditional pharmaceutical approaches, our implantable device removes the burden of dose regimen compliance from the patient.” Recent & Upcoming Events: About the EndoBarrier™ Gastrointestinal
Liner View this news release online at:
April, 2009 LEXINGTON, Mass.--(BUSINESS WIRE)-- GI Dynamics, a leader in non-surgical, endoscopic approaches for treating type 2 diabetes and obesity, today announced the presentation of new preclinical data for its EndoBarrier™ Technology. The study highlights the enhanced weight loss effects of combining the EndoBarrier Gastrointestinal Liner with a new EndoBarrier Flow Restrictor. The EndoBarrier Flow Restrictor provides an adjustable restriction at the outlet of the stomach and is designed to delay gastric emptying. Previous studies have demonstrated the dramatic weight loss and diabetes improvement achieved with the EndoBarrier Gastrointestinal Liner. This latest data suggest that the combination of the EndoBarrier Gastrointestinal Liner with the EndoBarrier Flow Restrictor could enhance the effectiveness of the liner by nearly doubling the amount of weight-loss achieved by using the liner alone. These preclinical data were presented by study investigator Keith Gersin, M.D., FACS, Chief of Bariatric Surgery at Carolinas Medical Center, and a member of GI Dynamics’ Scientific Advisory Board, during the Emerging Technology Session at the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) 2009 Annual Meeting in Phoenix, Arizona, on April 25, 2009 at 9:30 a.m. (MST). “These findings support what we have seen to date in other preclinical studies with both devices individually, confirming that combining the EndoBarrier Gastrointestinal Liner with the EndoBarrier Flow Restrictor have an enhanced effect on weight loss,” said Dr. Gersin. “In clinical studies of the EndoBarrier alone, we have seen a substantial effect on weight loss and resolution of type 2 diabetes, and we anticipate we will see enhanced weight loss with the combination of these two devices in human clinical trials.” “We are very pleased with the results seen in this study and the increased effect on weight loss seen with usage of both the EndoBarrier Gastrointestinal Liner and the EndoBarrier Flow Restrictor,” said Stuart A. Randle, chief executive officer of GI Dynamics. “We believe that the combination of these two devices impacts weight loss through distinct mechanisms of action and may truly represent a breakthrough in treating type 2 diabetes and obesity. GI Dynamics is conducting ongoing clinical studies investigating the synergistic effects of the combined devices and we look forward to sharing these results at an upcoming medical meeting later this year.” Overview of Preclinical Study Findings The preclinical study was designed to assess the effects on body weight in a porcine (pig) model of the EndoBarrier Flow Restrictor alone and in combination with the EndoBarrier Gastrointestinal Liner. In this study, the restrictor, with hole sizes ranging from 3 to 7 millimeters (mm) in diameter, was implanted endoscopically in the duodenum (first part of the small intestine) of the animals with a mean starting weight of 40.6±7.4 kilograms (kg). The modified device restricted the flow of partially digested food in the duodenum. For comparison, a control group underwent sham (control) endoscopic procedure. The animals were monitored for weight gain for up to 90 days and researchers evaluated daily general health and weekly weight of each animal and conducted monthly evaluations of the position and patency of the liner through fluoroscopy and endoscopy. In a separate experiment, the animals received either a 4 mm diameter restrictor device, the EndoBarrier Gastrointestinal Liner or a combination of the liner and the 4 mm restrictor. The findings demonstrate that treatment with the EndoBarrier Flow Restrictor limits weight gain in growing pigs to a similar degree as the EndoBarrier Gastrointestinal Liner, but when combined, both the liner and the flow restrictor resulted in approximately twice the effect on body weight compared to either treatment alone. The combination of the EndoBarrier Gastrointestinal Liner and the EndoBarrier Flow Restrictor with a 4 mm opening decreased weight gain to 0.16 ± 0.106 kg/day. This is significantly less than the decreased weight gain seen in the sham treatment group, which gained an average 0.41 ± 0.021 kg/day, and in the groups implanted with the EndoBarrier Flow Restrictors with openings of either 5 or 7 mm, which gained weight at the same rate (0.47 ± 0.026 kg/day and 0.42 ± 0.017 kg/day, respectively). The group implanted with the EndoBarrier Flow Restrictor with a 4 mm opening had a weight gain of 0.31 ± 0.014 kg/day which is significantly less weight gain compared to the sham treatment group (p=0.03) and similar to the standard, unmodified EndoBarrier Gastrointestinal Liner (0.26 ± 0.025 kg/day). About the EndoBarrier™ Gastrointestinal Liner GI Dynamics is developing the EndoBarrier Gastrointestinal Liner, an innovative, endoscopic and removable device, which is considered investigational and not yet commercially available. The EndoBarrier is currently being studied in clinical trials around the world as a potential treatment for patients with both type 2 diabetes and obesity. The EndoBarrier creates a physical barrier that lines the intestine to keep food from coming in contact with the intestinal wall. Physicians believe this may alter the activation of hormonal signals that originate in the intestine, and may mimic the effects of a Roux-en-Y gastric bypass procedure. However, the EndoBarrier procedure is done without the risks associated with highly invasive surgical procedures. The EndoBarrier is placed and removed endoscopically (via the mouth) without the need for surgical intervention or alteration of the patient’s anatomy. The EndoBarrier Gastrointestinal Liner in combination with the EndoBarrier Flow Restrictor can be customized to meet individual patient needs. Significant preclinical studies have confirmed that combining these two devices affects multiple mechanisms of action and enhances weight loss. Contacts Source: GI Dynamics
March, 2009 - The US patent
office has informed GI Dynamics investors Andy Levine, David Melanson,
John Meade and John Cvinar of the issuance of patent number 7,476,256
on January 13, 2009 describing a “Method and apparatus for limiting
absorption of food products in specific parts of the digestive system
is presented. A gastrointestinal implant device is anchored in the
duodenum and extends beyond the ligament of Treitz. All food exiting
the stomach is funneled through the device. The gastrointestinal device
includes an anchor for attaching the device to the duodenum and an
unsupported flexible sleeve to limit absorption of nutrients in the
duodenum. The anchor can include a stent and/or a wave anchor and is
collapsible for catheter-based delivery and removal.” www.uspto.gov
March, 2009 - Marquette, MI and Greenville, NC – Pioneer Surgical Technology, Inc., a leading innovator in the design and manufacture of spinal and orthopaedic implants, instruments and biologic products, today announced that it has won the prestigious Frost & Sullivan 2009 North American Technology Innovation of the Year Award for the E-Matrix™ Tissue Scaffold, recently launched in the United States. The patented E-Matrix technology provides a bioscaffold for leading edge biologic products in orthopaedics and other therapeutic areas. Pioneer’s CEO and President, Jeff Millin, noted, “This award reflects Pioneer’s commitment to deliver on innovation that benefits patients and surgeons, and is cost-effective for the healthcare system.” E-Matrix is the result of over ten years of dedicated research and development. Pioneer continues to focus on commercializing these
novel technologies and recently launched a bone graft substitute to the
US orthopaedic market utilizing the E-Matrix™ bioscaffold combined with
nanOss™, a proprietary nano-crystalline hydroxyapatite.
February, 2009 - GI Dynamics Closes an Additional $15 Million in Series C Financing LEXINGTON, Mass.--(BUSINESS WIRE)-- GI Dynamics today announced that it has closed an additional $15 million in Series C financing. With this additional funding, GI Dynamics has closed a total of $45 million in Series C financing, bringing the total raised by GI Dynamics since its inception to $61 million. Proceeds from this financing will be used to continue to advance the clinical development of the company’s EndoBarrier™ Gastrointestinal Liner and EndoBarrier platform of innovative medical devices for the treatment of metabolic disorders, including type 2 diabetes and obesity. To date, the EndoBarrier Gastrointestinal Liner has been studied in more than 175 patients demonstrating promising efficacy and safety data in both obese subjects and patients with type 2 diabetes. Participants in the round included all of GI Dynamics’ current institutional investors: Advanced Technology Ventures; Catalyst Health Ventures, Cutlass Capital; Domain Associates, LLC; Johnson & Johnson Development Corporation; and Polaris Venture Partners. “Attracting additional capital from leading investors and pharmaceutical organizations in this market is a testament to the progress we have made over the last several years and the significant commercial potential of our EndoBarrier™ Gastrointestinal Liner to treat metabolic disorders,” said Stuart A. Randle, chief executive officer of GI Dynamics. “This funding further strengthens our ability to aggressively advance EndoBarrier into the next stage of clinical trials for the treatment of type 2 diabetes and obesity, while continuing to develop additional products for the treatment of metabolic disorders based on the EndoBarrier intellectual property.” About the EndoBarrier™ Gastrointestinal
Liner About GI Dynamics Contacts View this news release online at:
January, 2009 - GI Dynamics
Receives ISO Certification and European CE Mark Approval for the
EndoBarrier™ Gastrointestinal Liner System
January, 2009 - GI Dynamics, a medical device company pioneering the development of new approaches to treat obesity and metabolic disorders, announced that it has received ISO 13485:2003 certification for the company’s Lexington facility. The company has also received European CE mark approval for the EndoBarrier™, its novel, noninvasive device currently in clinical trials to treat obesity and type 2 diabetes. For full press release: www.businesswire.com
November, 2008 - Pursuant to the
merger agreement between Pioneer Surgical Technology, Inc. and Angstrom
Medica, Inc., shares of Pioneer stock were placed in escrow on the
completion of the merger transaction in 2007. The Escrow Shares are now
released to Angstrom's Stockholders on the one year anniversary of the
Closing after having successfully cleared any claims for
indemnification by Pioneer or its affiliates. The Pioneer team is to be congratulated on their
fine work in accomplishing these two significant events in 2008. The
integration of Angstrom has been successfully completed and the
combined forces are working hard to achieve additional technology
milestones in the year ahead.
October, 2008 - The following announcement was sent to the shareholders of Pioneer stock on October 10, 2008 As we begin the 4th quarter, the days are getting shorter, the temperatures cooler, and the leaves are beginning to fall. As I view this change of season, I'm reminded to look back at the amazing things we have accomplished this year and look to the future with great confidence and pride. This year we have fully launched the SlimFuseTM Anterior Cervical Plate System, the Quantum® Complex Spine System, Cannulated Pedicle Screws for the Quantum Rod System, and most recently, the CrossFuseTM Lateral Option System and the ClarityTM Lateral Retractor System. The Cross-Fuse system is Pioneer's latest addition to a comprehensive family of PEEK (poly-ether-etherketone) VBRs. It was designed to be used with the Quantum Rod System and the Clarity Lateral Retractor System. Quantum Complex Spine was introduced to add deformity capability to the Quantum Rod system without adding difficulty or significant inventory. Cannulated Pedicle Screws were created to provide a minimally invasive option for the versatile Quantum system. SlimFuse is the only system on the market that offers standard and dynamic single screw per level plates with comparable stiffness of a 2 screw per level plate. All of these products have been well received by both surgeons and our sales force. The outlook for sales growth is extremely positive. In May, Pioneer announced the successful human implantation of its' next generation cervical total disc replacement (TDR), the NuNecTM Cervical Arthroplasty Device. Pioneer's P3 Technology- Pioneer PEEK-on-PEEK - platform of our motion preservation devices is the most sophisticated in the industry. The first series of patients have been completed and NuNec is CE marked and currently being introduced in Europe. In June 'BacJac' Interspinous Distraction System, the third in Pioneer's P3 Technology, was launched in Europe. This has been our most successful product introduction in the 16 year history of the company. July sales exceeded the entire 2008 forecast! BacJac is incredibly fast and easy to insert, has the elastic property of PEEK to prevent subsidence and is less invasive due to only a single fascial incision requirement. The Pioneer Orthobiologics team has reached a huge milestone with the 510K approval of FortrOssTM bone graft substitute. This is the culmination of over 10 years work by each of two companies, Encelle and Angstrom Medica that were acquired by Pioneer Surgical Technology in 2007. There have been 5 PhD engineers who have spent a good part of their life developing the components of FortrOss. FortrOss combines the nanotechnology of NanOss hydroxyapatite with the bone growth promotion of E-Matrix. Jeff Wang, MD will be presenting his research with FortrOss at NASS on Thursday, October 16 from 10:37AM to 10:42AM. This paper was runner up for the paper of the year award and is entitled, "A Novel Porcine Collage-derived Matrix as a Carrier for Recombinant Human Bone Morphogenetic Protein-2 Enhances Spinal Fusion in Rats". The first human implants of the Pioneer NanOss
cervical cage (VBR) which is pure nano-crystalline hydroxyapatite were
performed this summer and are performing very well. This pure HA cage
is twice as strong as PEEK cages and slowly incorporates into the human
bone.
September, 2008 - Pioneer® Surgical Technology Receives 510(k) Clearance to Market FortrOss™, A Next Generation Bone Void Filler - http://www.pioneersurgical.com/
September, 2008 - Over the past several weeks, GI Dynamics has received increased level of interest in both the popular press and at scientific meetings. Based on results presented in New York at a forum on new approaches to treating Type 2 diabetes and more recently in Buenos Aires at The International Federation for the Surgery of Obesity and Metabolic Disorders (IFSO), the EndoBarrier device is capturing enormous clinical excitement. At First World Congress on Interventional Therapies for Type 2 Diabetes in New York, Lee M. Kaplan, M.D., Ph.D., associate professor of medicine at Harvard Medical School and director of the Weight Center at Massachusetts General Hospital presented results in relieving Type 2 diabetes using EndoBarrier. In Buenos Aires Argentina, Dr. Jan Willem Greve and Dr. Ruben Schouten each presented recent data from Europe and South America on use of EndoBarrier in obese and diabetic patients. These clincal findings have inspired interest in the popular press. A number of links are provided for further information:
June, 2008 - GI Dynamics - Initial findings from interim analysis were presented at the American Diabetes Association 68th Annual Scientific Sessions, held this week in San Francisco, by Dr. Christopher Sorli, an endocrinologist at the Billings Clinic in Billings, MT. Early results indicate that non-surgical implant of the EndoBarrier impermeable liner into a portion of the small intestine results in rapid weight loss and remission of Type 2 Diabetes. The potential to control diabetes through the use of this non-invasive device means that doctors may be able to reduce or eliminate the need for diabetes drugs, and they may be able to delay or slow the progression of Type 2 Diabetes. http://www.primenewswire.com
May, 2008 - LumeRx reported several events concerning its plans moving forward. Trial results analysis from work recently completed in India reveals current visible light approaches are not adequate as a primary treatment for H. Pylori. As a result of these findings, the Company's investors have decided to not invest further in LumeRx and to scale back operations. Jon McGrath has stepped down from his position as CEO with day-to-day responsibilities assumed by David Hendren of Catalyst Health Ventures. Catalyst and other investors are now considering the future course for the LumeRx. http://www.masshightech.com
April, 2008 - Aesculap has informed Seedling Enterprises of the introduction of a new Multifunction Instrument for Laparoscopic Surgery. Aesculap a division of B Braun Melsungen AG commenced sale of its new line of laparoscopic surgical instruments that provide multi function capability in a single instrument. The device combines cutting scissor, grasping instrument, dissection instrument and cautery in a single device. In laparoscopic surgery current, single function devices require multiple exchanges to complete a procedure. The new multifunction instrument will save valuable operative time while reducing the possibility of adverse events associated with instrument exchange. The product was originally designed by Dr. Robert Hunt of Dover, MA and initially developed, tested and cleared through FDA by Seedling Enterprises. John Cvinar, Andy Levine and Josh Tolkoff, founders of Seedling Enterprises were instrumental in the product development and technology sale. http://patft.uspto.gov
March, 2008 - The United States Patent Office has informed John Cvinar and Andy Levine that it has issued patent number 7437875 describing: Methods of treatment using a bariatric sleeve . The patent defines a method and apparatus for limiting absorption of food products in specific parts of the digestive system. A gastrointestinal implant device is anchored in the stomach and extends beyond the ligament of Treitz. All food exiting the stomach is funneled through the device. The gastrointestinal device includes an anchor for anchoring the device to the stomach and a flexible sleeve to limit absorption of nutrients in the duodenum. The anchor is collapsible for endoscopic delivery and removal. http://patft.uspto.gov
October, 2007 - Pioneer Surgical Announces the Acquisition of Angstrom Medica. Pioneer Surgical Technology (PST) today announced its acquisition of Angstrom Medica, Inc., headquartered in Woburn, MA. Angstrom Medica was originally founder by Dr. Edward Ahn and received early funding from Seedling Enterprises. Angstrom is the first company to obtain Food and Drug Administration(FDA) approval for a nanotechnology device - NanOss™. NanOss chemistries enable products that are highly osteoconductive and can remodel over time into human bone. NanOss has potential application in trauma, spine and general orthopaedic markets. Terms of the acquisition were not disclosed. Angstrom Medica, Inc. becomes a wholly-owned subsidiary of PST and is part of its orthobiologics division. The transaction was managed at Angstrom Medica by Dr. Edward Ahn, CEO and John Cvinar, who had early in the venture served as CEO and continuously as member of the Board of Directors. http://www.pioneersurgical.com
September, 2007 - The United
States Patent Office has informed John Cvinar, David Melanson, John
Meade and Andy Levine that it has issued patent number 7267694
describing: Bariatric sleeve. The patent defines a method and apparatus
for limiting absorption of food products in specific parts of the
digestive system. A gastrointestinal implant device is anchored in the
stomach and extends beyond the ligament of Treitz. All food exiting the
stomach is funneled through the device. The gastrointestinal device
includes an anchor for anchoring the device to the stomach and a
flexible sleeve to limit absorption of nutrients in the duodenum. The
anchor is collapsible for endoscopic delivery and removal. http://patft.uspto.gov
August, 2007- The US Patent
Office has informed LumeRx of the issuance of patent 7261730
Phototherapy Device and Method. The patent describes physically
flexible radiation-emitting probes and associated illumination methods
and systems for delivering radiation or light to the interior of a
lumen or cavity. Light-emitting devices are immersed in a flowing
liquid coolant within a probe to provide high light output power, and
convoluted electrical power buss structures provide physical
flexibility of a probe about a longitudinal axis. The probes can be
configured for delivering light to the interior of any lumen including
for performing therapeutic medical procedures at locations in body
lumens including the interior of the human gastrointestinal tract. http://www.patentstorm.us
July, 2007 - Marlborough-based
LumeRx Inc. has closed the first portion of a $2 million mezzanine
round to fund a clinical trial of its visible light treatment for a
dangerous bacteria, according to a filing with the U.S. Securities and
Exchange Commission and the company's CEO. The trial, which began last
month in India, is a key step toward gaining clinical data to win
regulatory approval for the company's device for eradicating a
dangerous bacteria called H. pylori. The startup took in $585,000 last
month from the sale of convertible notes, according to the SEC filing.
The company has raised a total of $9 million from a Series A and
supplemental rounds. http://masshightech.bizjournals.com
June, 2006 - GI Dynamics Inc., a company developing minimally invasive devices for the treatment of obesity, has raised $30 million in Series C financing. New investor Johnson & Johnson Development Corp. led the round, joined by existing investors Catalyst Health and Technology Partners, Domain Associates, Cutlass Capital, Advanced Technology Ventures, Polaris Venture Partners and Seedling Enterprises. The company has filed a Form D with the Securities and Exchange Commission concerning the round. GI Dynamics raised a $4.1 million Series A round in July 2003 from ATV, Domain Associates and Polaris and a $12 million Series B round in May 2004 from ATV, Angel Healthcare Investors, Catalyst, Cutlass, Domain Associates, Polaris and Seedling. http://www.atvcapital.com
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