Musculoskeletal News Roundup 31-March-17

March 31, 2017 | Blake Mossy

M&A

Organogenesis entered into an agreement to acquire NuTech Medical, a developer of amniotic biologic products for the wound healing and surgical orthopedic markets. The transaction combines two companies with highly complementary regenerative wound care and surgical biologic product portfolios. Additionally, this acquisition allows Organogenesis to enter the amniotic segment of the biologics space. 

FUNDING

Medeon Biodesign closed a Series A investment in Panther Orthopedics, a San Jose, CA based start-up that developed fixation solutions for orthopedic extremity applications. Medeon, headquarter in Taipei, is a medical device developer of minimally invasive procedures for the treatment of a range of diseases, including orthopedics.

Merit Medical Systems revised  its public offering higher to $136.5 million from shares of common stock. Last week, the company commenced a public offering for the amount of  $125.0 million. The company intends to use the offering’s net proceeds to repay a portion of its debt obligations under the company’s outstanding credit facilities.

REGULATORY

Bodycad received 510(k) clearance from the FDA for its Bodycad Unicompartmental Knee System, a joint reconstruction implant. The system utilizes a 3D rendering of medical images of the patient’s anatomy to provide patient-specific implants and instruments for joint reconstruction, which aims to reduce trauma and increase the patient recovery speed. 

NuVasive received 510(k) clearance from the FDA for its CoRoent Small Interbody System, indicated for intervertebral body fusion at multiple contiguous levels in the cervical spine. The clearance covers the company's CoRoent Small (S), CoRoent Small Lordotic (SL), CoRoent Small Lordotic Plus (SLP), RoRoent Small Hyperlordotic (SHL), and CoRoent Small Contoured (SC). The system is a PEEK-optima based interbody cage that aims to provide stabilization of the spinal motion segment while fusion takes place.

Providence Medical Technology received 510(k) clearances from the FDA for the standalone use of its CAVUX Cervical Cage-L System and its ALLY Facet Screws. The CAVUX Cervical Cage-L System is a titanium implant offering a grit-blasted and acid-etched surfaces, large space for allogenic and autogenous bone grafts and utilizes self-drilling and self-tapping screws for standalone fixation. The Ally Facet Screw system is comprised of titanium screws that aim to provide temporary stabilization as an adjunct to spinal fusion.

PRODUCT INTRODUCTION & UPDATE

Integra LifeSciences launched its Cadence Total Ankle System, a new ankle prosthesis, commercially in Canada, the U.S. and select European regions. The system has been implanted in over 200 patients in seven countries, since initial clinical use. Candence utilizes side-specific anatomical tibial and talar components, as well as a highly crosslinked ultra-high molecular weight polyethylene for improved wear characteristics, and patent pending-biased sagittal profile options to address patients with subluxed talar anatomy.

INTELLECTUAL PROPERTY

Orthocell received a patent for its CelGro soft tissue reconstruction platform in Singapore. The patent covers the method of manufacture of novel bio-scaffolds to aid in the surgical repair of soft tissue injuries such as tendon, nerve, cartilage and bone, as well as the delivery of stem cells to relevant surgical sites. The system has previously received patents in the U.S., Canada, China and New Zealand.

CLINICAL

Additive Orthopaedics announced the commencement of a multi-center clinical study to measure bone-growth into its 3D printed bone segments. The company has implanted over 200 individual devices since its first commercial product launch at the end of 2016.

 Burst Biologics received IRB approval for its multicenter prospective clinical study in spinal fusion patients, using its BioBurst Fluid, a cellular allograft derived from umbilical cord blood (UCB) which has previously shown positive results in spinal fusion procedures. Fifteen clinical sites will participate throughout the U.S. with an enrollment of 450 patients.

OrthAlign announced a milestone achievement in its 60,000^th completed joint arthroplasty case. The company provides a computer-assisted, handheld technology that utilized real-time data for alignment and positioning of components in total knee, unicondylar knee, and totally hip arthroplasty surgeries.

RepliCel Life Sciences reported results from its phase I/II tendon repair study investigating the use of its type 1 collagen-expressing, hair follicle-derived fibroblasts as a treatment for Achilles tendinosis. The study results indicated no serious adverse events related to the study at 6 months. All patient’s treated suffered chronic tendon pain and loss of function over an extended period of time with no recovery from standard treatments, showed clinical improvements by various measures including tendon composition, blood supply, physical function and pain sensation.

Z-Medical announced the first open surgery utilizing its MIS Z-Pedicle Screw System, a pre-sterilized implant designed to reduce surgical steps in minimally-invasive or open trauma or spondylisthesis procedures. The system aims to offer reduced tissue disruption and blood loss during surgeries.

APPOINTMENTS

 Alphatec Holdings, Inc., the parent company of Alphatec Spine, Inc., a provider of spinal fusion technologies, announced the addition of two new executives with proven track records in the spine industry, naming Brian Snider as Executive Vice President, Strategic Marketing and Product Development, and Chris Ryan as Area Vice President of Sales in the U.S. Central Region.  Drawing on their deep commercial spine experience, Mr. Snider and Mr. Ryan will focus on building brand awareness with surgeon customers and driving market demand for Alphatec's differentiated product solutions. Mr. Snider has spent the past 11 years focused on marketing, brand and product development, and global product management in the spine and medical device industries.  Prior to joining Alphatec Spine, Mr. Snider spent nine years at NuVasive, Inc. Mr. Ryan brings more than 20 years of progressive spine sales leadership experience to Alphatec.  Prior to joining Alphatec, Mr. Ryan held multiple sales leadership roles over a six-year period with Zimmer Biomet Spine, including as its Vice President of U.S. Sales and a member of the Zimmer Spine Leadership Team.

Providence Medical Technology appointed Scott Lynch to lead Global Marketing, and Michael Scott to assume International leadership. Prior to Providence Medical Technology, Mr. Lynch served as Vice President of Global Marketing at DFINE, VertiFlex, and Zimmer Spine. Mr. Scott previously served as Vice President Vice President OUS Sports Medicine at ArthroCare, Vice President of Asia Pacific Commercial Operations, and U.S. Vice President ENT Sales at Smith & Nephew.