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Clinical and Industry News

Industry Insider News

August 2018

KeraNetics Merges With Microchips Biotech, Creates New Company

Officials at KeraNetics LLC, a company based in Winston-Salem, NC, that provides treatment options for wound management, advanced wound healing, and tissue repair, have announced a merger agreement with Microchips Biotech Inc. (Lexington, MA), a company that produces microchip-based implants that can store and release drug doses over months and/or years. The collaboration creates a new company — Keratin Biosciences Inc. — and is expected to advance patient care in the fields of regenerative medicine and drug delivery. 

“We’re excited to bring together two talented organizations committed to becoming leaders in regenerative medicine and drug delivery,” said Cheryl Blanchard, PhD, who will serve as president and chief executive officer of Keratin Biosciences, which will remain in operation in both North Carolina and Massachusetts. “Our goal is delivering important solutions to patients in need.”

The company will aim to bring transformative new products to market that promote regenerative healing of complex tissue injuries, as well as skin wounds and conditions based on a purified human-derived keratin (a fibrous structural protein) technology platform.Blanchard, described as a pioneer in keratin science by company officials, said the merged company is “a synergistic combination of leadership with deep technical and commercial skills and confidence in the great promise of keratin as a clinically important biomaterial platform.” KeraNetics has a decade’s experience in keratin-based research and development to address an array of unmet medical needs. Kim Westmoreland, formerly KeraNetics’ chief executive officer and now chief strategy officer of Keratin Biosciences, said the new partnership “presents an opportunity to accelerate delivery of new products to heal injuries sustained by our wounded warfighters and civilian patients with skin injuries and conditions. A tough, natural constituent of skin and hair that serves an important natural barrier function, keratin possesses unique qualities to produce first-in-class treatments for skin wounds and burns and the potential for aiding development of regenerative therapies for muscle, nerve, and bone, officials said. Addition, the company will reportedly seek to exploit the advantages of keratin as a multi-modal drug-delivery agent. Keratin Biosciences has 510(k) clearance to market KeraStat,® a novel topical dressing for advanced wound care, officials said. Keratin Biosciences will also reportedly continue to pursue development of implantable drug delivery for contraception begun by Microchips Biotech and will seek licensees of the technology for other applications. “Our aim is to expand our collaborations with academic and medical research communities in both Boston and North Carolina that we’re so fortunate to have in our backyards,” Blanchard said. For more information, visit https://keranetics.com or https://microchipsbiotech.com/index.php. 

SANUWAVE, HyperMed Announce Joint Investigational Partnership for Diabetic Foot Ulcers

A recently formed partnership between two medical device companies is expected to create a sponsorship for a continuing clinical investigation on diabetic foot ulcers (DFUs). According to officials with SANUWAVE® Health Inc. (Suwanee, GA) and HyperMedTM (Memphis, TN), the two organizations are collaborating on investigational work slated to begin in August. An initial case series will be conducted at two sites, with the primary site reportedly being the Vascular and Wound Care Center at University Hospital, Rutgers NJMS in Newark, NJ, and the second site at Olive View-UCLA Medical Center in Los Angeles, CA. Oscar M. Alvarez, PhD, will serve as the principal investigator at Rutgers while Aksone Nouvong, DPM, FACFAS, will lead the efforts at UCLA, officials said. The intent of the trial will reportedly be to quantify the level of increased perfusion and oxygenation during and after treatment with the dermaPACE® System, a SANUWAVE product. Previous animal studies and clinical work using dermaPACE have shown that treated tissue exhibits increased perfusion to the area, as measured by Doppler imaging, and an increase in venule and arteriole diameters, indicating increased red blood cell velocity, officials said. This case series will also utilize HyperMed’s HyperViewTM spectral imaging device to measure oxygen saturation, oxyhemoglobin level, and deoxyhemoglobin level in superficial tissue and using transcutaneous oximetry values as a control. As a result of Alvarez’s leadership and case work, he will be able to provide valuable, measurable data to continue to expand the understanding of dermaPACE’s mechanism of action, officials said, while Nouvong has already performed and published extensive research using HyperView. With their combined expertise, these practitioners are expected to expand the already extensive clinical data associated with dermaPACE, officials said. Both researchers previously participated in DFU trials involving dermaPACE.

“We are very excited about this next opportunity to investigate the effects that the dermaPACE System has on improving perfusion and oxygenation in treated tissue,” said Kevin A. Richardson II, SANUWAVE’s chairman of the board and chief executive officer.  “This case series will enable us to quantify the increases and help us to better understand how dermaPACE improves patients’ quality of life, leading to future research and improvement of clinical protocols for the treatment of diabetic foot ulcers and other skin conditions.”

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