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Orthopedic and Dental Industry News Complete Archive »

Printable Weekly

Musculoskeletal News Roundup 20-Jan-17

M&A
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.

FUNDING
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.

REGULATORY
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.

PRODUCT INTRODUCTIONS & UPDATES
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.

DISTRIBUTION
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.

CLINICAL
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.



OrthoSpace Announces Enrollment Milestone in the InSpace Pivotal Study

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.

“Patient interest in the InSpace device for massive rotator cuff repair is accelerating, and our investigator teams, who recognize the potential value of this device, remain committed to meeting enrollment targets and the continued collection of high-quality data,” commented Nikhil N. Verma, M.D., of Rush University Medical Center and the Principal Investigator for the study. “The treatment of massive, irreparable rotator cuff tears remains a challenge for physicians and patients, and we are optimistic that, upon marketing approval by the FDA, the InSpace device will provide a valuable, simple and safe option for pain relief in this patient population.”

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. The study’s primary efficacy outcome is the change in the Western Ontario Rotator Cuff Index (WORC), which assesses patient-reported quality-of-life metrics, at 12 months post-operatively when compared to baseline. Secondary outcomes measures include changes in American Shoulder and Elbow Surgeons (ASES) scores, changes in Constant shoulder outcome scores and changes in Quality of Life (as measured by the EuroQOL [EQ-5D-5L] five dimensions questionnaire) at up to two years of follow-up.

InSpace is currently commercially available outside of the United States and has been implanted in over 10,000 patients in 15 countries. Details for the U.S. pivotal study, including participating institutions and complete eligibility requirements, are available at ClinicalTrials.gov under identifier NCT02493660.

About OrthoSpace Ltd.
OrthoSpace is a privately held medical device company located in Caesarea, Israel. The Company's product, InSpace, is an orthopedic biodegradable balloon system that is simple, safe and a minimally invasive method that addresses unmet clinical needs in rotator cuff repair. InSpace is CE Marked and commercialized in Europe and Israel and has been granted an Investigational Device Exemption (IDE) to initiate a pivotal human clinical study of the InSpace System in the United States.


Well-Controlled Clinical Study Published by Journal of Clinical Orthodontics Demonstrates Effect of Vibration on Molar Distalization Using AcceleDent

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. AcceleDent is also the first and only FDA-cleared vibratory orthodontic device that is clinically proven to speed up orthodontic treatment by as much as 50 percent when used in conjunction with braces or aligners. The gentle vibrations have also been clinically shown to reduce patient discomfort during orthodontic treatment.

In the study, Bowman evenly divided 60 adolescent patients into two groups. Half of the patients were in the control group and the remaining 30 patients were in the vibration group. Patients in the vibration group were asked to use AcceleDent for 20 minutes daily by holding the device's mouthpiece between their teeth. All 60 patients were non-extraction cases and each patient was treated with a miniscrew implant-supported device (Horseshoe Jet) for achieving distalization, the correction of the posterior position of the upper molars.

Bowman found that there was 71 percent more movement of the molar root apex (2.9mm vs. 1.7mm per month) and a modestly significant 27 percent increase in crown movement (1.1mm vs. .9mm per month) in the AcceleDent group than the control group. Additionally, the desired Class I molar relationship was achieved an average of 27 days faster in the AcceleDent group.

"From my previous retrospective investigation of vibrational effects on leveling and alignment of the mandibular dentition, a statistically significant 30 percent increased rate of leveling was revealed. It appears that there is a concurrent increase in the rate of molar movement when AcceleDent is used as a treatment adjunct during Class II malocclusion correction," said Bowman, a highly regarded orthodontic specialist who practices at Kalamazoo Orthodontics in Michigan. "It was also interesting to note that AcceleDent had no impact on miniscrew failure rates."

Bowman adds that he measured patient compliance throughout the study to accurately report the impact of AcceleDent compliance on study outcomes. Among the compliant patients in the AcceleDent group, the average molar movement was 1.23mm per month compared to .89mm per month for the noncompliant patients. The compliant group achieved Class I within 186 days and level mandibular dentition in 65 days. The noncompliant group achieved Class I in 220 days and level mandibular dentition in 106 days.

"This study by Dr. Bowman was very targeted and thorough in its approach and evaluation of AcceleDent's impact on molar distalization," said Kathy Farley, OrthoAccel's vice president of clinical education. "It's a significant contribution to OrthoAccel's clinical library of 15 peer-reviewed articles, including three randomized controlled trials. These published articles demonstrate how AcceleDent can be successfully integrated into clinical practice with a variety of preferred orthodontic appliances and treatment protocols to improve predictable outcomes and enhance patient satisfaction."

The article was published in the November 2016 issue of JCO and can be viewed here. Bowman's previous study on leveling and alignment appeared in the November 2014 issue of the JCO and available here. An interactive version of OrthoAccel's comprehensive peer-reviewed clinical evidence can be found here. Each clinical article can be viewed by clinking on the article's title. For more information about clinically proven accelerated orthodontics with AcceleDent, visit AcceleDent.com.

About OrthoAccel Technologies, Inc.

OrthoAccel Technologies, Inc. is a privately owned medical device company engaged in the creation, manufacturing, marketing and sales of innovative solutions that enhance dental care and orthodontic treatment. Among the company's innovations is AcceleDent, an FDA-cleared, Class II medical device that employs patented SoftPulse Technology that is clinically proven to speed up bone remodeling during orthodontic treatment by enhancing physiological bone turnover. These safe and gentle vibrations accelerate tooth movement by as much as 50 percent and reduce discomfort associated with treatment. OrthoAccel, the Leader in Accelerated Orthodontics, has received positive feedback from patients and leading orthodontists from around the world who report increased mechanical efficiency with orthodontic appliances and improved predictability of clinical outcomes with AcceleDent. Ranked on Deloitte's 2016 Technology Fast 500 as one of the fastest growing companies in North America, OrthoAccel is based in Houston, Texas and maintains a global presence through its EMEA office in Essen, Germany. To learn more about OrthoAccel's focus on improving the journey to healthy, beautiful smiles, visit AcceleDent.com.


OrthoAccel Technologies, Inc. Announces $15 Million Series C Financing

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.

“We remain excited about OrthoAccel’s global market opportunity and AcceleDent’s position as the market leader of the accelerated orthodontic category,” said Brian R. Smith, managing director of S3 Ventures. “With continuously high satisfaction marks from patients and reports of enhanced predictability and improved practice economics from leading orthodontists using AcceleDent, we remain committed to driving future growth.”

This financing round comes as OrthoAccel CEO Michael K. Lowe announces that he is stepping down and Kelly Enos, the company’s chief financial officer, will serve as interim CEO while a search is conducted by the board. Lowe will continue to advise the board during the leadership transition.

“I’m proud of what our team has accomplished and the timing is right for this transition as OrthoAccel enters its next phase of growth as the leader in accelerated orthodontics,” said Lowe.

John McCormick, managing director of HealthpointCapital, credits Lowe’s visionary leadership for bringing AcceleDent to market, building a world-class innovation company and maintaining market leadership as new market entrants emerged.

“We greatly appreciate Mike’s contributions to the growth of this company and for his dedication to orthodontic innovation,” said McCormick. “As we look forward to this next phase of OrthoAccel’s growth, we remain committed to the orthodontic industry, helping orthodontists achieve predictable outcomes and enhancing the treatment experience for patients.”

McCormick adds that with OrthoAccel’s position as the leader of the accelerated orthodontic category comes the responsibility of having strong clinical evidence that proves the new technology’s benefits and effectiveness. OrthoAccel’s clinical library includes 15 peer-reviewed studies, three randomized controlled trials, several case studies, and testimonials from leading orthodontists demonstrating that AcceleDent enhances treatment efficiency and improves predictable clinical outcomes.

For more information about OrthoAccel, visit AcceleDent.com.

About OrthoAccel Technologies, Inc.
OrthoAccel Technologies, Inc. is a privately owned medical device company engaged in the creation, manufacturing, marketing and sales of innovative solutions that enhance dental care and orthodontic treatment. Among the company’s innovations is AcceleDent, an FDA-cleared, Class II medical device that employs patented SoftPulse Technology® that is clinically proven to speed up bone remodeling during orthodontic treatment by enhancing physiological bone turnover. These safe and gentle vibrations accelerate tooth movement by as much as 50 percent and reduce discomfort associated with treatment. OrthoAccel, the Leader in Accelerated Orthodontics, has received positive feedback from patients and leading orthodontists from around the world who report increased mechanical efficiency with orthodontic appliances and improved predictability of clinical outcomes with AcceleDent. Ranked on Deloitte’s 2016 Technology Fast 500 as one of the fastest growing companies in North America, OrthoAccel is based in Houston, Texas and maintains a global presence through its EMEA office in Essen, Germany. To learn more about OrthoAccel’s focus on improving the journey to healthy, beautiful smiles, visit AcceleDent.com.


Musculoskeletal News Roundup 13-Jan-17

M&A
Integra LifeSciences entered into an agreement to acquire Derma Sciences Inc., a publicly traded wound care company for a total enterprise value of $147 million, or 1.7x LTM revenues of $88.5 million. Under the terms of the transaction, Integra will purchase all of the outstanding shares of Derma Sciences common stock for $7.00 per share in cash through a tender offer. Through this transaction, Integra is acquiring an amniotic tissue-based platform technology that further broadens the company's proprietary regenerative technology capabilities and helps supplement Integra's 3x3 wound care strategy. The deal is expected to close at the end of the 1Q:17. Integra intends to fund the transaction through an existing credit facility.

REGULATORY
Medicrea filed a 510(k) submission with the FDA for its 3-D printed Titanium interbody devices with compatible UNiD Lab surgical planning and analytical services. The system aims to enable the surgeon to pre-operatively define the exact 3-D printed interbody anatomical specifications matched with a predictive analysis of global spinal alignment parameters.

Orthofix received premarket approval from the FDA and European CE Mark approval for its CervicalSTIM and SpinalStim bone growth stimulators. The devices are designed to use low-level pulsed electonmagnetic field (PEMF) in order to activate and augment the body's natural healing process as a noninvasive treatment option for promoting post-operative spinal fusion. The U.S. approval includes the Stim on Track mobile app to support patient engagement and real-time delivery of data to the physician.

PRODUCT INTRODUCTION & UPDATE
Johnson & Johnson announced the launch of its CareAdvantage initiative, a holistic, data-driven system that seeks to help healthcare facilities navigate a more value-based care environment and improve patient care, by leveraging and drawing insights out of the clinical, consumer and operational capabilities of J&J's medical device companies. CareAdvantage is designed to help health care facilities and their suppliers meet such value-based goals and bring greater value throughout the continuum of care. The initiative builds a level of comprehension for each individual health system, then develops a customized plan of action aimed at delivering value across a patient's episode of care.In conjunction with CareAdvantage, J&J also launched its Orthopaedic Episode of Care Approach, a comprehensive offering designed to help health systems and surgeons reduce costs and increase quality to drive improvements in orthopedic care and achieve the goals of value-based alternative care models, such as the Centers for Medicare & Medicaid Services' (CMS') Comprehensive Care for Joint Replacement (CJR) and the Surgical Hip and Femur Fracture Treatment (SHFFT) Models, under which orthopedic surgeons will be measured by Medicare on performance during a patient's episode of care.

DISTRIBUTION
Medovex entered into an international distribution agreement with AlfaMed for the distribution of its DenerveX System throughout Italy. Under the terms of the agreement, AlfaMed will provide sales, marketing and distribution services for launch of the DenerveX System in the region when it is commercially available. The system is designed to provide a minimally invasive treatment option which combines two actions into one single-use device.

OssDsign entered into commercial partnerships covering the distribution of its products for cranial repair and facial bone reconstruction in Italy, Spain, Switzerland, Austria and The Netherlands. The company's products, OSSDSIGN Cranial and OSSDSIGN Facial are currently marketed in Germany, The UK and as well as selected non-European markets. OssDsign intends to focus on building sales on its innovative products through a combination of internal sales organization and distribution partnerships.

Orthocell entered into a research collaboration agreement with DePuy Synthes Products for its Ortho-ATI stem cell approach for the regeneration of degenerate tendons and ligaments. The system is a non-surgical approach to treat chronic treatment resistant tendon injuries that negatively effect patients' activities of daily living.

CLINICAL
Amedica announced the first successful surgery using its Taurus Pedicle Screw System a modular degenerative system, connecting strength with intra-operative flexibility. The system is intended to immobilize and stabilize the spinal segments to supplement fusion of the lumbar and/or sacral spine.

CartiHeal announced initial cases in Europe using its next-generation version of Agili-C unicondylar implant, designed for the treatment of large cartilage lesions, typical of patients suffering from osteoarthritis. The implant has been implanted into 250 patients throughout Europe in clinical trials in the knee, ankle and big toe.

Histogenics published clinical results from Phase I and Phase II study indicating that its NeoCart tissue-engineered implant is a safe, effective treatment for articular cartilage lesion through 5-year follow-up. The results indicated that the system provides a faster and more durable recovery for patients with cartilage defects in the knee. The publications analyzed magnetic resonance imaging data throughout 29 patients during a 60 month period.

Vertebral Technologies (VTI) announced the successful outcome of the first lumbar fusion procedure in Mexico using its InterFuse laterally expandable device. InterFuse is designed to allow surgeons to implant a large footprint device through a minimally-invasive posterior approach in patients with acute disc herniation and those suffering from spondylolisthesis, segmental instability and spinal stenosis.




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