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Seedling
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Announcements and Press Releases 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% 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. About the EndoBarrier™ Gastrointestinal Liner The patented EndoBarrier Gastrointestinal Liner is an advanced investigational, non-surgical medical device based on the EndoBarrier Technology platform for treating type 2 diabetes and obesity. The EndoBarrier Gastrointestinal Liner is placed in the GI tract endoscopically (via the mouth) to create a barrier between food and the wall of the intestine. Physicians believe that preventing food from coming into contact with the intestinal wall may alter the activation of hormonal signals that originate in the intestine, thus mimicking the effects of a Roux-en-Y gastric bypass procedure without surgery. A growing body of pre-clinical and clinical evidence supports the potential for EndoBarrier Gastrointestinal Liner to dramatically change the treatment landscape for people living with type 2 diabetes, obese people at risk for type 2 diabetes, and people with severe weight problems. About GI Dynamics GI Dynamics is focused on developing effective, non-surgical approaches for treating type 2 diabetes and obesity. The company’s patented EndoBarrier™ Technology has the potential to deliver medical interventions for people combating weight problems and diabetes or diabetes risk factors. Data from clinical trials demonstrate that the EndoBarrier™ Gastrointestinal Liner, an advanced device in the EndoBarrier portfolio, may provide rapid improvement in glycemic control and significant weight loss by modifying metabolic pathways. The company is also developing the EndoBarrier Flow Restrictor, which is designed to further enhance the effectiveness of the liner by doubling the amount of weight-loss that can be achieved using the liner alone. Each device in the EndoBarrier portfolio is designed to assist patients gain control of their blood sugar and achieve a healthier body mass index (BMI). GI Dynamics is collaborating with experts in endocrinology, gastroenterology, bariatric surgery and medical weight loss on these efforts. Based in Lexington, Massachusetts and founded in 2003, GI Dynamics is backed by top-tier investors including Advanced Technology Ventures, Catalyst Health Ventures, Cutlass Capital, Domain Associates, Johnson & Johnson Development Corporation, and Polaris Venture Partners. For more information, visit GI Dynamics online at www.gidynamics.com.
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. About the EndoBarrier™ Gastrointestinal Liner The patented EndoBarrier Gastrointestinal Liner is an advanced investigational, non-surgical medical device based on the EndoBarrier Technology platform for treating type 2 diabetes and obesity. The EndoBarrier Gastrointestinal Liner is placed in the GI tract endoscopically (via the mouth) to create a barrier between food and the wall of the intestine. Physicians believe that preventing food from coming into contact with the intestinal wall may alter the activation of hormonal signals that originate in the intestine, thus mimicking the effects of a Roux-en-Y gastric bypass procedure without surgery. A growing body of preclinical and clinical evidence supports the potential for EndoBarrier Gastrointestinal Liner to dramatically change the treatment landscape for people living with type 2 diabetes, obese people at risk for type 2 diabetes, and people with severe weight problems.
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. About GI Dynamics GI Dynamics is a clinical-stage medical device company pioneering the development of devices that influence multiple metabolic pathways to improve glycemic control in patients with type 2 diabetes and achieve weight loss in obese patients. The Company’s patented EndoBarrier™ Technology has the potential to deliver immediate metabolic control by modifying metabolic pathways. GI Dynamics is developing the EndoBarrier, a platform of endoscopic, removable devices that line a portion of the small intestine, mimicking the effects of Roux-en-Y gastric bypass surgery without the risks associated with highly invasive surgical procedures. Clinical trials are ongoing to evaluate longer-term clinical benefit of the EndoBarrier for the treatment of type 2 diabetes and obesity. Based in Lexington, Massachusetts and founded in 2003, GI Dynamics is backed by top-tier investors including Advanced Technology Ventures, Catalyst Health Ventures, Cutlass Capital, Domain Associates, Johnson & Johnson Development Corporation, and Polaris Venture Partners. For more information, visit GI Dynamics online at www.gidynamics.com. 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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