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Orthopedic and Dental Industry News Complete Archive »

Musculoskeletal News Roundup 20-Jan-17 BY BLAKE MOSSY, JANUARY 20, 2017

China-based MicroPort Orthopedics invested $15 million in Lombard Medical Technologies for a 29% ownership stake and partnership deal. Under the terms of the agreement, Microport and Lombard entered into a component supply manufacturing deal, with Microport manufacturing components for the Alutra and Aorfix at its Shanghai facilities. Through the partnership, Lombard will seek to accelerate commercialization of its Arofix and Altura stent grafts for treating abdominal aortic aneurysms, while Microport will gain exclusive marketing rights for both products in China and Brazil, as well as a license to manufacture the products for the Chinese marketplace.

Abyrx secured $10 million in a round of financing led by Canaan Partners, MedEdge, BB Biotech Ventures, with participation from members of the company’s executive team. The new capital will be used to support Abyrx’s bone putty products and to accelerate pipeline developments.

ApiFix closed $5 million from a Series B investment round led by B. Braun's Melsungen Aesculap division. ApiFix offers a minimally invasive, non-fusion spinal implant system for the correction of Adolescent Idiopathic Scoliosis (AIS).

AVEX LLC secured $7.6 million in a Series A financing that will be used for the launch of the company's Footbeat, wearable technology that improves health and athletic performance by increasing circulation through precise, cyclic pressure applied to the arch of the foot, in 1Q:17. The device aims to increase circulation in patients’ lower extremities and is designed for comfort and to be mobile and easy-to-use.

ConforMIS secured $50 million in debt financing from Oxford Finance and filed a shelf registration statement for up to $200 million of its common stock, preferred stock, debt securities, or warrants. Under the terms of the debt agreement, ConforMIS can initially access $15 million of debt and an additional $15 million will be made available through December this year. Another $20 million will be available through June 2018 and is pegged to certain revenue milestone. The company plans to use the debt financing and shelf registration to support commercialization efforts of its custom joint replacement implants.

Genalyte raised $36 million in a round of financing led by Khosla Ventures and Redmile Group. The company is developing its Maverick Detection System, a diagnostic platform of tests that can be performed at a doctor's office in under 15 minutes and only utilize one drop of blood to diagnose diseases like rheumatoid arthritis (RA).

Intrinsic Therapeutics raised $17.9 million in a new round of financing from 18 anonymous sources. The company offers the Barricaid system, an adjunct for lumbar limited discectomy to replace missing or damaged parts of the anulus to prevent re-herniation, disc collapse, the return of sciatica in order to help treat low back pain. The company is aiming to bring in another $2.3 million before closing the round.

Milestone Scientific secured a $3 million through a public offering of approximately 2 million shares at a price $1.50 per share. Under the terms of the offering, each share includes warrants for the purchase of an additional 0.75 common shares of stock, offering an additional total 1.5 million shares. Warrants offered in the round have a three-year term and an exercise price of $2.55 per share. The company plans to use the proceeds for a HFV study, which aims to demonstrate the ease-of-use of itsCompu-Flo intra-articular computer controlled injection system.

NeuroMetrix raised $26.5 million through a public offering of common stock. Under the terms of the offering, the shares of common stock were priced at 70¢ per share, via a warrants exercise, which have an exercise price of 70¢ per share and will expire five years after the issuance date. The company anticipates to utilize approximately $19.5 million from the offering to redeem 19,450 shares of Series D convertible preferred stock and retire 25 million warrants to purchase outstanding common stock. The remaining proceeds will go towards commercialization of the company’s wearable device for chronic pain relief in the U.S. and for general corporate purposes. NeuroMetrix also secured an additional $7 million through a private offering of 7,000 shares of Series E convertible preferred stock at $1,000 apiece, as well as warrants to purchase 10 million shares of common stock at an exercise price of ¢70 per share.

OrthoAccel Technologies, Inc. today announced a $15 Million Series C financing project that includes the privately held innovation company’s institutional equity investors, S3 Ventures, HealthpointCapital and Piper Jaffray Merchant Banking. OrthoAccel Technologies is the manufacturer and marketer of AcceleDent, the first and only FDA-cleared vibratory orthodontic device that is clinically proven to speed up bone remodeling by employing SoftPulse Technology that stimulates cellular activity and enhanced physiological bone turnover.

Providence Medical Technology closed a $10.5 million round of equity financing with MVM Life Science Partners, a new investor, leading the financing and Stanmore Medical Investments and Aphelion Capital also participating in the round. The company plans to use the funding to support the commercialization of its tissue-sparing cervical fusion technology portfolio.

Spineway secured €1.4 million ($1.5 million) by issuing 355,260 new shares of common stock, with warrants attached, to China-based TINAVI Medical Technologies. Spineway develops implants and ancillary surgical equipment for the treatment of severe vertebral pathologies.

Supercraft3D raised $1 million to help support the development of its 3D medical models based on CT scans, MRIs and x-rays, in addition to implants and surgical instruments that use biocompatible titanium alloy.

Titan Spine secured $1.5 million in a Series B financing involving nine undisclosed investors. The company closed financing rounds of $202,262 in October and $7.5 million in June. Titan Spine develops titanium interbody spinal implants for promoting bone growth.

Trice Medical secured $5 million through a round of debt financing. The company offers the mi-eye device, which utilizes a disposable needle that comes with a fully integrated camera to facilitate in-office diagnosis of joint injuries. mi-eye 2 is designed to provide illumination and visualization of an interior cavity of the body through either a natural or surgical opening. The company hopes to secure $6.3 million for the round in total.

CyMedica Orthopedics received 510(k) clearance from the FDA for its e-vive, an app-controlled, data-driven muscle activation therapy and patient engagement solution designed for at-home rehab muscle strengthening for ACL and total knee replacement patients. The app works with embedded garment sensor technology to transmit data points directly to a secure cloud-based portal, allowing providers to track patient progress and patient-reported measures.

Osseon received a patent from the United States Patent and Trademark Office (USPTO) for its Steerable and Curvable Cavity Creation System, a bone augmenting system for the treatment of compression fractures in the spine. The aims to produce a growing line of products for spinal compression fractures and plans to launch more devices this year.

Precision Spine received 510(k) clearance from the FDA for its ShurFit ACIF 2C Anterior Cervical Interbody System, manufactured from PEEK Optima and coated with titanium and hydroxyapatite to facilitate bone ongrowth during the fusion process. The system is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine at one disc level and consists of implants with various heights to accommodate individual patient anatomy and graft material size.

SpineGuard received 510(k) clearance from the FDA for its DSG (Dynamic Surgical Guidance) integration module technology to be used with the company's partner, Zavation's pedicle screws. The device uses a combination of a bipolar sensor and a pedicle screw to allows the surgeon real-time guidance and the ability to insert the screw into a vertebra without drilling a pilot hole.

Safe Orthopaedics launched a bone substitute for its Walnut cervical cage in European. The device aims to promote bone growth during cervical surgeries to make vertebral fusion sager. The company also received 510(k) clearance from the FDA for itsSteriSpine CC range, which includes the Walnut cage.The technology is not yet commercialized in the United States, but aims to gain rapid approval in certain counties such as Latin America and the Asia-Pacific region.

Zebra Medical Vision developed an algorithm capable of decting vertebral fractures for inclusion in its Deep Learning Imaging Analytics platform. The algorithm uses deep learning to differentiate between compression fractures and degenerative endplate changes and oestophytes, and may be used to accurately identify at-risk patients to reduce the risk of additional osteoporotic fractures. Once the algorithm is released commercially, it will be offered as part of Zebra's Imaging Analytics engine for care providers, as well as on its Profound platform, which allows users to upload their imaging scans and receive automated insights regarding their imaging data.

Bioventus announced that MEDSERVICE will distribute its DUROLANE in Russia. DUROLANE is a single-injection joint-fluid based on a technology process called NASHA which yields stabilized hyaluronic acid (HA). MEDSERVICE will offer DUROLANE that is indicated for the symptomatic treatment of mild to moderate knee or hip osteoarthritis (OA) and DUROLANE SJ associated with mild to moderate osteoarthritis pain in the ankle, elbow, wrist, fingers, and toes.

Bovie Medical entered into a global sales channel partnership agreement with CONMED for its PlazXact Ablator, which will be marketed as the UltrAblator Bipolar series in March 2017. The PlazXact Ablator is a single-use, sterile device for the cutting, coagulating and ablation of soft tissue in arthroscopic procedures.

OrthoAccel Technologies, Inc. announced that the Journal of Clinical Orthodontics (JCO) has published "The Effect of Vibration on Molar Distalization," a study that focused on adolescent patients. Conducted by Dr. S. Jay Bowman, this prospective, peer-reviewed clinical study concluded that when treating Class II malocclusions, AcceleDent's SoftPulse Technology speeds up molar distalization rates in the apex and crown while also reducing the number of days to move the upper molars into a normal, Class I relationship. Manufactured by OrthoAccel, AcceleDent employs patented SoftPulse Technology that is clinically proven to speed up bone remodeling during orthodontic treatment by enhancing physiological bone turnover, thus enabling orthodontists to achieve predictable clinical outcomes.

OrthoSpace Ltd. (“OrthoSpace” or “the Company”) announced that it has surpassed the midway point for patient enrollment in its U.S. Investigational Device Exemption (IDE) pivotal study of the InSpace biodegradable balloon system for the treatment of massive rotator cuff tears. Enrollment of 184 patients at 19 North American sites is on track to be completed by the end of 2017, demonstrating a brisk pace of patient accrual and ongoing momentum for this technology as the Company prepares its FDA marketing submission. The study is a randomized, single-blinded, controlled study that compares the InSpace System to conventional repair or partial repair of full-thickness massive rotator cuff tears. Patients will be followed for adverse events and other safety measures.

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