October 17, 2017: TransMed7, LLC Announces 510(k) Submission to the U.S. FDA for its SpeedBird Soft Tissue Biopsy Device Platform
Portola Valley, CA, October 17, 2017; TransMed7, LLC today announced that it has submitted a premarket notification for its innovative SpeedBird soft tissue biopsy device platform with the US Food and Drug Administration (FDA), under Section 510(k) of the Food, Drug and Cosmetic Act. “We are pleased to announce this 510K submission to the FDA, which represents the final countdown to the rapid market launch of our SpeedBird 38, Universal, and SBU 99 soft tissue biopsy devices in the United States, expected in the first quarter of 2018,” said Eugene H. Vetter, TransMed7’s Co-Founder and CEO.
The SpeedBird product platform of hand-held soft tissue biopsy devices has been designed to fulfill the needs of surgeons, radiologists, and other clinicians who desire better minimally invasive procedures through the use of next-generation, cost-effective, single insertion and multiple sample (SIMS) biopsy devices in a choice of sizes and which is designed to consistently and safely obtain higher quality biopsy samples from the breast, liver, kidney, prostate, spleen, lung, lymph nodes, and other soft tissue abnormalities identified by physical exam, X-rays, or ultrasound.
In anticipation of 510(k) clearance, TransMed7 is finalizing production and market introduction strategies for the SpeedBird product platform rollout for both domestic and international sales and distribution. Additionally, TransMed7 is continuing development of its portfolio of next generation products based on innovative variations of its patented “Zero5” working element, which include: Concorde™, a new platform technology for stereotactic and MRI based biopsy procedures; Cardinal, a fine-needle core biopsy device for breast, thyroid, and lymph nodes; and Cygnet, a novel device designed to establish continued access for intervention including aspiration and biopsy of bone marrow. TransMed7 is also currently developing Martinet™, a revolutionary new minimal access device for complete removal of target tissue.
According to Dr. James W. Vetter, TransMed7 Co-Founder and Chairman, “We are delighted to achieve this important milestone as it puts TransMed7 closer to its goal of developing critically needed, minimally-invasive medical technologies and getting them into the hands of clinicians for the benefit of their patients as quickly as possible.”
Caution: The SpeedBird 38, Universal, and SBU 99 soft tissue biopsy devices are investigational devices, which pending FDA clearance, are not as yet available for sale.
October 10, 2017: TransMed7, LLC Announces Endocrine and GI Health Chair Appointment
TransMed7, LLC today announced the appointment of Michael J. Demeure, MD, MBA, as Chair of its Endocrine and Gastrointestinal (GI) Health Team and Member of its Executive Team of TransMed7’s Clinical and Scientific Advisory Board (CSAB). “We are honored to have Dr. Demeure as Chair of our Endocrine and GI Health Team. Recognized as one of the top surgeons in the United States, Dr. Demeure is keenly interested in new transformational medical technologies that will help all physicians realize more precise diagnostic and therapeutic interventions,” said Eugene H. Vetter, TransMed7’s Co-Founder and CEO. “In his role, he will be responsible for leading TransMed7’s Endocrine and GI Health Team in achieving our goal of developing and rapidly fielding new minimally invasive medical technologies integrated with advanced imaging modalities, beginning with Cardinal™ – our new platform technology for fine-needle core biopsy procedures”.
Dr. Demeure is the Program Director for Precision Medicine at the Hoag Family Cancer Institute and a fellowship-trained endocrine surgeon with the Newport Irvine Surgical Specialists group. He is also an Adjunct Professor at the Translational Genomics Research Institute (TGen), and previously a Clinical Professor of Surgery at the University of Arizona, College of Medicine in Phoenix, AZ. Dr. Demeure is a 1983 graduate of Hahnemann Medical College and completed his surgical residency at the University of Arizona. He subsequently completed a fellowship in endocrine surgery in Perth, Australia and at the University of California, San Francisco. He previously held faculty positions at the Medical College of Wisconsin, as Professor and Chief of General Surgery at the University of Arizona, and most recently as Scientific Director, Center for Pancreatic and Endocrine Surgery, Scottsdale Healthcare and Professor and Director of the Rare Tumors Program in the Division of Integrated Cancer Genomics at TGen. In 2007, Dr. Demeure completed his MBA at the University of Arizona.
Dr. Demeure is an internationally recognized expert in cancer surgery and research with particular expertise in endocrine, pancreatic and gastrointestinal cancers. In addition to a very active clinical practice, Dr. Demeure has led a highly productive research lab for over 20 years focused on using genomic technologies to develop novel biomarkers, new therapeutic targets, and related therapies in the management of endocrine and gastrointestinal cancers; this has led to his being the Co- or Principle Investigator on several of the landmark trials in these same areas. Dr. Demeure is the author or co-author of over 100 scholarly works and he has given over 150 invited lectures and presentations. Dr. Demeure is a past-President of the American Association of Endocrine Surgeons, is regularly recognized as one of “America’s Top Surgeons” and has been named as one of the “Best Doctors in America” every year since 2001. Prior to his move to the Hoag Family Cancer Institute at Hoag Hospital, he helped TGen with the launch and direction of Ashion Analytics, a commercial clinical sequencing lab serving as its Chief Medical Officer, Executive Vice-President and General Manager.
“I am delighted to be joining TransMed7’s talented and enthusiastic team of clinicians, scientists, and engineers in developing and implementing new breakthrough diagnostic and therapeutic technologies for the benefit of patients everywhere”, said Dr. Demeure.
According to Dr. James W. Vetter, TransMed7 Co-Founder and Chairman, “Dr. Demeure brings valuable leadership experience in the rapidly expanding field of precision medicine and distinctive expertise in endocrine and gastrointestinal diseases. We look forward to his guidance as we build on our strengths in the field of image-guided, minimal access intervention to rapidly make a difference in the lives of patients in need”.
FOR IMMEDIATE RELEASE: September 25, 2017
TransMed7, LLC Announces Breast Health Chair Appointment
TransMed7, LLC, announced the appointment of Richard E. Fine, MD, as Chair, Breast Health Team and Member, Executive Team of TransMed7’s Clinical and Scientific Advisory Board (CSAB). “We are honored to have Dr. Fine as Chair of the distinguished leaders in our Breast Health Team. He brings to our organization more than 20 years’ experience as a nationally recognized pioneer in breast care”, said Eugene H. Vetter, TransMed7’s Co-Founder and CEO. “In his new role, he will be responsible for helping TransMed7 and particularly, our Breast Health Team, achieve their goal of developing critically needed, minimally-invasive medical technologies and getting them into the hands of clinicians for the benefit of their patients as rapidly as possible, with particular emphasis on launching Concorde™, our new platform technology for stereotactic and MRI based biopsy procedures, and Martinet™, our novel minimal access device for complete removal of target tissue”.
Since 2012, Dr. Fine has been the Director of Education and Research at the Margaret West Comprehensive Breast Center. In addition, he is the Program Director, West Cancer Center Breast Surgical Oncology Fellowship and Associate Professor in the Department of Surgery, Division of Surgical Oncology at the University of Tennessee Health Science Center, College of Medicine. Dr. Fine holds or has held several positions of national prominence in breast care including Presidency of the American Society of Breast Surgeons from 2003-2004, Chairman of the Board of the American Society of Breast Surgeons, Chairman of the Board of the American Society of Breast Surgeons Foundation, Co-Chair of the American College of Surgeons National Ultrasound Faculty Breast Imaging Module, and Board Member of the National Accreditation Program for Breast Centers (NAPBC) and the National Consortium of Breast Centers (NCBC).
Dr. Fine received his undergraduate degree in Chemistry at Emory University, Atlanta, GA, in 1979 and his MD at the Medical College of Georgia, Augusta, GA, in 1983. He subsequently performed his Surgery Residency at Rush-Presbyterian-St. Luke’s Medical Center from 1983-1988 in association with noted breast care pioneers, Dr. Steven G. Economou and Dr. Kambiz Dowlatshahi. Dr. Fine has received numerous awards including the American Medical Association Physicians Recognition Award, 1991-2010, and most recently recognition as a “Top Doctor” in Memphis Magazine, 2014-2017.
A highly sought-after educator and acknowledged thought leader in the use of ultrasound and image-guided technology, Dr. Fine has published numerous articles and written several book chapters related to stereotactic and ultrasound core needle breast biopsy. He continues as a member of several breast research endeavors including the Scientific Advisory Board for the IceCure™ Medical IceSense3 Cryotherapy for Breast Cancer Trial and multiple clinical studies on Image-guided Breast Biopsy Technology. Dr. Fine has served on numerous advisory panels for both established and start-up organizations in developing and bringing to market new technology in the breast space. “I am delighted to be part of the talented team of committed clinicians, scientists, and engineers at TransMed7, all dedicated to provide difference making minimal access medical technology for patients with breast disease”, says Dr. Fine.
According to Dr. James W. Vetter, TransMed7 Co-Founder and Chairman, “Dr. Fine is a true innovator in the diagnosis and treatment of breast diseases. In addition to being one of the first surgeons in the country to perform stereotactic-guided needle core biopsy, he has since remained on the forefront of education and technology development in the field of image-guided, minimal access breast intervention”.
FOR IMMEDIATE RELEASE: September 11, 2017
TransMed7, LLC Announces Strategic Partnership with Peridot Corporation
Portola Valley, CA, September 11, 2017; TransMed7, LLC, today announced a Strategic Partnership between TransMed7, LLC and Peridot Corporation effective August 21, 2017. Both are privately held companies: TransMed7 designs and develops transformational medical device technologies for diverse fields of healthcare while Peridot offers complete end-to-end precision manufacturing and clean room assembly services.
“This new Strategic Partnership with Peridot enables TransMed7 to launch new products such as our Concorde™ and Martinet™ technologies directly into the market immediately following FDA clearance. Peridot was our contract manufacturer for our SpeedBird™ platform needle sets, and we are excited to be expanding our relationship with Peridot for timed product commercial release in significant quantities for strategic market penetration, ” said Eugene H. Vetter, TransMed7’s Co-Founder and CEO. According to Dr. Edgar D. Staren, TransMed7’s President and President of Martinet Medical, LLC, a TransMed7 subsidiary Project Company, “TransMed7’s technology pipeline covers multiple, diverse medical fields with broad applications including breast, abdominal, thoracic, head and neck, urologic, endoscopic, robotic, laparoscopic, and therapeutic endovascular. This partnership with Peridot positions TransMed7 well to provide the novel, revolutionary tools for the great many fields where targeted, minimally invasive approaches are determined to be the preferred option”.
“The Peridot Team is truly gratified and very excited to have been chosen as the Strategic Partner by TransMed7 in this endeavor. Peridot’s deeply diverse technical capabilities in the field of minimally invasive devices coupled with our demonstrated agility will certainly enable TransMed7 to meet and exceed their clinical goals. This is an incredible opportunity for Peridot to be at the forefront of developing technologies that are sure to lead to better patient outcomes”, said Patrick Pickerell, Peridot Co-Founder and President.
According to Dr. James W. Vetter, TransMed7 Co-Founder and Chairman, “Peridot’s established leadership position highlights their ability to apply the widest and most enabling range of manufacturing capabilities far upstream into initial iteration phases, to which they have coupled unmatched quality and tracking systems that mesh perfectly with TransMed7’s own industry-leading standards of quality during creation, verification and validation phases. As a result, together we are able to streamline the entire process from initial design, to clearance, and to market release with instruments ready for widespread distribution and confident clinical use. TransMed7 and Peridot share a rare, profoundly important synergism, which results in a collective capability to satisfy our mutual passion to vastly accelerate development and delivery of the most cost-effective, highest quality, safest and by far most advanced technologies possible–to patients around the globe”.
About Peridot Corporation
Peridot Corporation offers complete end-to-end precision manufacturing and clean room assembly services to a wide range of industries. With over twenty years’ experience with device fabrication and precision miniature and micro-miniature component assembly, Peridot can design, prototype, test and deliver products with the utmost precision and versatility. At Peridot we actively and avidly engage with our customers in all phases of pre-production planning and production, as well as material and cost analysis. Our thorough working knowledge of production processes, materials and finishes becomes an integral part of a customer’s planning process resulting in our delivery of manufactured custom components that are as precisely functional as they are perfectly beautiful. Moreover, from the smallest micro-miniature components to the biggest new ideas, we bring unmatched quality and precision to every medical product we manufacture. For more information about Peridot Corporation, please visit our website at www.peridotcorp.com.
FOR IMMEDIATE RELEASE: July 24, 2017
TransMed7, LLC Announces Appointment of Jack Cumming as Director
Portola Valley, CA, July 24, 2017: TransMed7, LLC today announced the appointment of industry veteran Jack Cumming as a member of its Board of Directors. Mr. Cumming currently serves as CEO & Managing Director of Cumming & Associates, LLC, a strategic advisory firm formed in 2014 to exclusively serve the healthcare industry.
Prior to launching Cumming & Associates, Mr. Cumming spent fourteen years at Hologic, Inc., a publicly listed NASDAQ company. He joined Hologic in August 2000 as Senior Vice President and President of Lorad, a Hologic company. Mr. Cumming was promoted to President & CEO of Hologic in 2001 and later assumed the role as Chairman. He stepped down as Chairman in September of 2011 to serve as Global Strategic Advisor with a focus on expanding Hologic’s international presence. However, in July of 2013 the Board of Directors asked Mr. Cumming to reassume the role of President & CEO with the express direction of restructuring the company. Mr. Cumming formally retired from Hologic in December of 2013.
Under Mr. Cumming’s leadership of Hologic, beginning in 2001, Hologic’s market capitalization increased from $78 million to over $10 billion, while revenues grew from approximately $100 million to over $2.5 billon. Moreover, during this time period the company acquired over a dozen companies whose products harmonized their women’s health care portfolio. Hologic achieved an unprecedented market share leadership position in nine categories spanning Breast Health, Diagnostics, and Surgical. Mr. Cumming directly attributes this achievement to the entire Hologic team whose passionate, dedicated, and unwavering belief in making a difference in the lives of women differentiated them from their competitors. In 2007, Frost & Sullivan named Mr. Cumming CEO of the Year. In 2011, Mr. Cumming was named recipient of the 2011 National Consortium of Breast Centers Inspiration Award winner.
“Jack’s proven leadership and extreme business acumen immediately expand TransMed7’s strategic options for rapid deployment of our transformational technologies into the market,” said Eugene H. Vetter, TransMed7’s Co-Founder and CEO. TransMed7’s President, Dr. Edgar D. Staren stated that, “Jack’s unique depth of industry knowledge and proven success will help us advance our business as we bring to market medical technology which addresses patient needs from diagnosis to therapy.”
Prior to joining Hologic, Mr. Cumming served as President and Managing Director of HealthCare Markets Group (HCMG), a strategic advisory and investment-banking firm he founded in 1984. In his capacity as Managing Director of HCMG, the firm completed over $2.0 billion in transactions. Mr. Cumming is Trustee of Counsel at Bentley University and is also a member of the Luther Rice Society of The George Washington University. He joined the Board of T2 BioSystems in 2014 and serves on its corporate governance and nominating committees. Mr. Cumming also serves as a member of the Finance Committee for the Radiological Society of America. Mr. Cumming and his wife Pamela are active in the Cumming Family Foundation, which was established to fund projects primarily focused on health issues for women and children globally.
Mr. Cumming stated, “I am delighted to join the TransMed7 Board because I view their products as transformational, having the breadth of scope and runway of potential applications to multiple diseases, including breast tissue biopsy and excision, bone marrow biopsy and aspiration, cardiovascular intervention, endoscopy, laparoscopy, and others. TransMed7’s multiple, worldwide, and interlocking patent coverage of all aspects of its next generation minimal access medical technology position it to provide highly reliable, multi-use devices that are cost-effective and built to ensure ease of use by clinicians and enhanced access for patients.”
According to Dr. James W. Vetter, TransMed7’s Co-Founder and Chairman, “Jack’s exceptional leadership and management experience will continue to be instrumental in formulating our strategic direction as we advance TransMed7’s prime objective of improving each patient’s treatment, care, and quality of life through delivery of our innovative pipeline of transformational medical devices”.
FOR IMMEDIATE RELEASE: June 15, 2017
TransMed7, LLC Announces Appointment of Dr. Edgar Staren as President
Portola Valley, CA, June 15, 2017: TransMed7, LLC today announced the appointment of Edgar D. Staren, MD, PhD, MBA as TransMed7’s President as well as President of Martinet Medical, LLC, a new subsidiary Project Company among its portfolio, effective July 1, 2017. “Dr. Staren brings more than 20 years’ experience as a successful healthcare executive leading clinical programs, facilities, and biotechnology startups as well as operations management in both for-profit and not-for-profit arenas”, said Eugene H. Vetter, TransMed7’s Co-Founder and CEO. “In his new role, Dr. Staren will be responsible for taking our overall business strategy to the next level, as well as managing operations, quality, and financial performance for both TransMed7 and each of our Project Companies. We are fortunate to be able to add Dr. Staren’s leadership and experience to our mix, and look forward to the new impetus he brings to the growth of our business.”
Dr. Staren will be leaving his current position as Professor of Surgery, VP and Executive Director for Cancer Services at Wake Forest University Baptist Health, and Deputy Director for Clinical Affairs of its Comprehensive Cancer Center where he fostered tremendous growth in cancer services, enhanced clinical efficiencies, and drove substantial increase in operating income. Immediately prior to this he served as CEO of Ashion PMed Management, LLC and President of its subsidiary, Ashion Advanced Individual Medicine, LLC, both outgrowths of the Translational Genomic Research Institute (TGen) and now an affiliate of the City of Hope Comprehensive Cancer Center.
A graduate of Loyola University School of Medicine, Dr. Staren received his surgical training at Rush University Medical Center and Cook County Hospitals; he remained at Rush as a faculty member where he held positions as Professor and Associate Dean. He subsequently was recruited as Professor and Chairman of Surgery at the Medical College of Ohio and Medical Director of the MCO Cancer Institute. He then served as Senior Vice President and Chief Medical Officer, Western Regional Medical Center CEO, and CEO of Cancer Treatment Centers of America (CTCA) Medicine and Science before joining Ashion.
Dr. Staren has been regularly listed in “Best Doctor’s in America” and “America’s Top Doctors for Cancer”. He is a member of numerous academic organizations including the American Surgical Association, the American Society of Clinical Oncology, and the Society of Surgical Oncology, and he is a Past President of the American Society of Breast Surgeons. He has published nearly 300 scientific works including more than 150 manuscripts, 80+ abstracts, 45 book chapters, and 12 books. He has given more than 200 visiting professorships or invited lectures. “I feel most fortunate to be joining a remarkably talented team dedicated to bringing their combined expertise to bear in order to make a difference in the lives of patients in need”, says Dr. Staren.
According to Dr. James W. Vetter, TransMed7 Co-Founder and Chairman, “Dr. Staren has been a pioneer and strong advocate for the enhanced use of minimally invasive, image-guided procedures throughout his career. Along with his proven operational excellence, Dr. Staren brings his extensive experience with the latest diagnostic and treatment advances to further advance TransMed7’s prime objective of improving each patient’s treatment, care and quality of life through practical translation of new capabilities and concepts into our pipeline of transformational devices”.