SANTA MONICA, Calif., June 11, 2013 /PRNewswire/ — Leonhardt Ventures and CORE Manufacturing, LLC, are pleased to announce a new partnership. Leonhardt Ventures has partnered with CORE Manufacturing to manufacture and bring to market a lineup of breakthrough medical technologies, including:
- MyoStim Heart Pacer ) – First heart pacemaker designed to recruit reparative stem cells to damaged or weakened heart tissue via a homing signal. The recruited stem cells are converted to working heart muscle.
- Stem Cell Pump – First implantable, wirelessly recharged pump designed to deliver controlled dosages of stem cells and growth factors to selected organs for recovery and repair.
- AortaCell – First non-invasive device that focuses electrical energy wirelessly onto weakened aortic vessel walls to recruit stem cells and convert those cells into smooth muscle to repair an aortic aneurysm without surgery or intervention. This wireless electrical energy/stem cell technology will be the basis of a number of follow-on developments by this team.
- CoroStim – The first vibrational-energy-emitting pacemaker add-on designed to prevent arterial plaque formation in high-risk patients.
CORE Manufacturing is a relatively new entity in a long-standing active implantable device cGMP manufacturing facility. While the entity is new, the CORE Manufacturing team has active implantable device development and manufacturing experience dating back to the 1970s. Under the new agreement, CORE Manufacturing will provide world-class manufacturing services for active implantable devices on behalf of Leonhardt Ventures' portfolio of companies and developments. CORE Manufacturing is a unique resource for OEMs looking for commercialization of complex medical devices, with capabilities that include rapid-turn prototyping and full turnkey device-level assembly, sterilization and testing, specializing in active implantable devices. The combination of CORE Manufacturing's world-class assembly and test capability with CIRTEC's advanced active implant design, development and pilot manufacturing enables Leonhardt Ventures' portfolio companies to leverage the most sophisticated, single-stop outsource solution for bringing their active implantable devices to market safely, without the enormous expense and risk of developing this capability internally.
"We have long admired the team at CORE Manufacturing, as they have helped save and improve millions of lives with their research and developments," said Howard Leonhardt, Founder, Chairman and CEO of Leonhardt Ventures. "We are thrilled to have the opportunity to partner with them. The CORE Manufacturing facility and team is exactly what we needed to bring our breakthrough developments to market."
Joel Hirsch, President of CORE Manufacturing, stated, "CORE Manufacturing is honored to partner with Leonhardt Ventures and MyoStim Pacers. CORE is uniquely qualified to develop and manufacture the lineup of Leonhardt Ventures' active implantable devices. We are excited to be involved with devices that could truly change the course of care for millions of patients in great need of these innovative and advanced solutions."
Alan Remen, CEO of MyoStim Pacers, affirmed, "The CORE Manufacturing team has a strong track record of developing and manufacturing high-quality active implantable devices. We are ready to roll up our sleeves and plow through the hard work to bring to market what we believe to be the most advanced and useful heart pacemaker ever invented."
Leonhardt added, "This engagement of services is really about the quality and experience of the people at CORE Manufacturing. Their qualifications for this work are unmatched worldwide."
Alex S. Richardson, Founder of CORE Manufacturing, has 30 years of experience in high-reliability manufacturing. After serving in the United States Air Force as an Avionics Navigation Engineer, Richardson launched his professional career in the private sector in engineering, quality, operations, business development and key executive roles for distinguished OEMs and manufacturers such as ITT Gilfillan, JPL/NASA and Stellar Microelectronics (Flextronics). Over the last three decades, he has been instrumental in launching a myriad of complex products in the military/aerospace and medical device market sectors with a forte in radar systems, unmanned aerial vehicles (UAVs), military radios, countermeasures, Class II and III implantable medical devices, and other products that push the technology envelope. Richardson has spent the last 14 years supporting several Alfred Mann companies and maintaining successful partnerships with other medical device entities such as Advanced Bionics, Biotronik, Boston Scientific, GE Medical, Medtronic, St. Jude Medical and other world-class organizations.
David L. DeMuth, Manufacturing Manager of CORE Manufacturing, has extensive experience with Class III medical device manufacturing, including product design, manufacturing engineering and operations management. He has spent 13 years designing and developing complex and precision medical devices and bringing them to market. DeMuth's experience with CORE and Tiger Team includes project implementation, production process and design validation, and clinical trials. His projects have included primary and secondary implantable-battery design and manufacturing, along with one of the most technologically advanced implantable drug infusion systems available. Prior to joining CORE Manufacturing, DeMuth's related work history included Quallion, Medical Research Products, Advanced Bionics, Boston Scientific and most recently the Alfred Mann Foundation. He has multiple patents issued and additional published patent applications, and he is a member of ASME. DeMuth has completed ongoing education through affiliations with ASPE and APICS.
Joel Hirsch, President of CORE Manufacturing, has over 30 years of experience in the consumer electronics, aerospace and medical electronics arenas. He spent the majority of his career at Teledyne, with ever-increasing operational responsibilities culminating in the role of Group Executive supervising multiple business units. Since then, Hirsch has worked with private equity investors in managing portfolio businesses and evaluating investment opportunities. His relationship with the Alfred Mann companies started over 25 years ago as a supplier of hybrid electronics for early versions of implantable pacemakers. Hirsch is pleased to renew this relationship through CORE Manufacturing.
About CORE Manufacturing, LLC: CORE Manufacturing is located in Valencia, Calif., about 25 miles north of Los Angeles, in proximity to a hub of medical-product OEMs. CORE Manufacturing is well positioned for the manufacture of highly complex medical devices at production rates and has a highly skilled staff of manufacturing, process and regulatory professionals. CORE Manufacturing is a spin-out of the Alfred Mann Foundation, which retains a passive investment position within the organization. On March 8, 2013, CIRTEC announced a major investment in CORE Manufacturing; see http://www.cirtecmed.com/PR_CoreMfg.html.
About Leonhardt Ventures: Since 1983, Leonhardt Ventures <http://www.leonhardtventures.com> has a strong history of inventing, developing, backing, manufacturing and bringing to market leadership products for treating heart and cardiovascular disease. Over 200,000 patients have been treated to date with Leonhardt inventions. In the 1980s, the group developed market leadership in patented cardiovascular polyurethane balloon catheters. In the 1990s, they developed over 20 additional devices including the first commercially successful stent graft for aortic aneurysm repair: TALENT – Taheri-Leonhardt Stent Graft. The team completed the first-ever percutaneous repair of an aortic aneurysm without surgery in Melbourne, Australia, in 1995. Leonhardt also developed and patented the first percutaneous heart valve, intravascular lung catheter, the Pro-Cell intracavity stem cell delivery system and the MyoCath line of stem cell delivery catheters. Leonhardt-patented inventions include MyoStim Pacers – the first heart pacemaker able to recruit reparative stem cells to damaged heart tissue and to differentiate those cells into new beating, pumping heart muscle – and CoroStim, the first vibrational-energy device to prevent arterial plaque formation. In 2001, the team led the world's first non-surgical case of stem cell repair of damaged heart muscle in a human patient with Bioheart MyoCell. That led to the first Phase II/III double-blinded, randomized, placebo-controlled trial for muscle stem cells growing new contractile muscle in post-heart-attack tissue in advanced heart-failure patients, with results published in the American Heart Journal Fall 2011 issue: Bioheart MyoCell patients achieved 95.7 meters improvement in exercise capacity over placebo (minus 4 meters decline). The team is preparing to complete the first-ever biological pacemaker made entirely of living cells (BioPace); working with Utrecht University, they anticipate implantation in a human patient within the next 12 months. Recently, the team initiated the development of the first implantable stem cell pump.
Howard Leonhardt, Leonhardt Ventures
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