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Cartiva Announces First UK Patient Treated in Study of Cartiva® SCI for Pain Associated with Osteoarthritis of the Thumb

16th February 2016

Cartiva Announces First UK Patient Treated in Study of Cartiva® SCI for Pain Associated with Osteoarthritis of the Thumb
Study to Evaluate Safety and Effectiveness of Cartiva SCI in the treatment of first carpometacarpal (CMC) joint osteoarthritis

ALPHARETTA, Ga. Cartiva, Inc., a developer of innovative solutions for the treatment of cartilage damage, osteoarthritis and other musculoskeletal conditions, announced that the first patient in the United Kingdom has been treated in its GRIP Study, a multi-center study evaluating the safety and effectiveness of Cartiva Synthetic Cartilage Implant (SCI) in the treatment of first carpometacarpal (CMC) joint osteoarthritis at the base of the thumb. Mr. Chris Bainbridge, MB ChB, FRCSEd, the Co-Principal Investigator of the GRIP Study, performed the surgery at The Pulvertaft Hand Centre within the Royal Derby Hospital in Derby, England.

Cartiva SCI is a proprietary hydrogel polymer device designed to mimic natural cartilage. The implant is used in the treatment of osteoarthritis in patients with diseased or damaged articular surface in the first CMC joint. Cartiva SCI is implanted in the metacarpal base, where its placement provides replacement for damaged cartilage without requiring the destruction or removal of a patient’s healthy tissue. The design of the Cartiva implant minimizes bone resection and preserves the trapezium and may provide for a quicker and less painful recovery than ligament reconstruction tendon interposition (LRTI) surgery or trapeziectomy. Also, because the procedure preserves normal joint anatomy, LRTI or trapeziectomy remain viable options if a revision is ultimately required. The Cartiva implant is currently available in Europe and Canada.

"We are excited to have treated the first UK patient in this multicenter study, said Mr. Bainbridge, Consultant Hand Surgeon at the Pulvertaft Hand Centre. “Cartiva SCI is an innovative implant that may offer advantages over current procedures. Evaluating new technology with the goal of improving patient outcomes is part of our ongoing effort to deliver the best patient care possible."

About the GRIP Study

The GRIP study is a prospective feasibility Phase II study to evaluate the safety and effectiveness of Cartiva SCI in the treatment of first carpometacarpal (CMC) joint osteoarthritis. The objectives of the study are to evaluate the safety and effectiveness of Cartiva SCI for CMC in terms of pain relief and improvement of joint function and to evaluate Cartiva SCI for CMC device performance in order to establish the parameters for a pivotal trial. A total of 50 patients will be treated with Cartiva at ten sites across Canada and the United Kingdom. Participating sites and principal investigators include the following:

Participating Institution Location Principal Investigator
United Kingdom
Royal Derby Hospital Derby, England Chris Bainbridge, MD
Royal United Hospital Bath, England Grey Giddins, MD
South Tees Hospitals NHS Foundation Trust Middlesbrough, England Sanjay Miranda, MD
Queen Alexandra Hospital Portsmouth, England Philip Sauvé, MD
Woodend Hospital Aberdeen, Scotland David Lawrie, MD
Canada
QEII Health Sciences Centre Halifax, Nova Scotia Andrew Trenholm, MD
University of British Columbia, Vancouver Vancouver, British Columbia Erin Brown , MD
University of Calgary Calgary, Alberta Jonathan Lee, MD
Sunnybrook Health Sciences Centre Toronto, Ontario Paul Binhammer, MD
University of Alberta Edmonton, Alberta Mike Morhart, MD

About Osteoarthritis of the CMC Joint

Also known as thumb basal joint arthritis, osteoarthritis of the CMC joint is a common and frequently debilitating condition that affects 8% to 12% of the general population and as many as 33% of postmenopausal women. Osteoarthritis of the CMC joint causes pain, swelling, instability, deformity, loss of motion and weakness, making it difficult to perform a variety of tasks, such as turning doorknobs and opening jars. Current surgical options for later-stage patients for whom conservative treatments have failed include joint fusion, total or partial trapeziectomy or arthroplasty.

About Cartiva, Inc.

Based in Alpharetta, Ga., Cartiva, Inc. develops and markets innovative solutions for patients with osteoarthritis, cartilage damage and other musculoskeletal conditions. Cartiva’s venture investors include New Enterprise Associates, Windham Venture Partners and Domain Associates. Additional information is available on the company’s website at www.cartiva.net.

Cartiva Announces First Patient Treated in Study of Cartiva® Synthetic Cartilage Implant for Pain Associated with Osteoarthritis of the Thumb

24th September 2015

(Alpharetta, GA, September 24, 2015) – Cartiva, Inc., a developer of innovative solutions for the treatment of cartilage damage, osteoarthritis and other musculoskeletal conditions, announced that the first patient has been treated in its GRIP Study, a multi-center study evaluating the safety and effectiveness of Cartiva Synthetic Cartilage Implant (SCI) in the treatment of first carpometacarpal (CMC) joint osteoarthritis at the base of the thumb. Erin Brown, MD PhD FRCSC, the Co-Principal Investigator of the GRIP Study, performed the surgery at UBC Hospital in Vancouver, British Columbia. This procedure was also the first to utilize this Cartiva implant design, using implants and tools optimized for the specific curvatures of the CMC joint.

Osteoarthritis of the thumb CMC joint is a common and frequently debilitating condition that affects 8% to 12% of the general population[1] and as many as 33% of postmenopausal women[2]. Also known as thumb basal joint arthritis, osteoarthritis of the CMC joint causes pain, swelling, instability, deformity, loss of motion and weakness, making it difficult to perform a variety of tasks, such as turning doorknobs and opening jars. Current surgical options for later-stage patients for whom conservative treatments have failed include joint fusion, total or partial trapeziectomy or arthroplasty.

Cartiva SCI is a proprietary hydrogel polymer device designed to mimic natural cartilage. The implant is used in the treatment of osteoarthritis in patients with diseased or damaged articular surface in the first CMC joint. Cartiva SCI is implanted in the metacarpal base, where its placement provides replacement for damaged cartilage without requiring the destruction or removal of a patient’s healthy tissue. The design of the Cartiva implant minimizes bone resection and preserves the trapezium and may provide for a quicker and less painful recovery than ligament reconstruction tendon interposition (LRTI) surgery or trapeziectomy. Also, because the procedure preserves normal joint anatomy, LRTI or trapeziectomy remain viable options if a revision is ultimately required. The Cartiva implant is currently available in Europe and Canada.

“We are excited to be the first hospital to enroll a patient in this study,” said Dr. Brown, Clinical Professor and Director of Research, Division of Plastic Surgery at the University of British Columbia. “The Cartiva device is implanted in a quick and straightforward procedure, and has the potential to restore grip and pinch strength following debilitating osteoarthritis of the CMC joint. I look forward to enrolling additional patients and following them on a longer-term basis, which will help examine the potential of this promising technology.”

“Enrolling the first patient in our feasibility study is an important milestone for our company and the physician community and underscores our commitment to developing innovative and data-supported products for orthopedic extremities patients,” said Timothy J. Patrick, president and chief executive officer of Cartiva.

[1] Lawrence JS, Bremner JM, Bier F. Osteo-arthrosis. Prevalence in the population and relationship between symptoms and x-ray changes. Ann Rheum Dis. 1966;25: 1-5.
[2] Armstrong AL, Hunter JB, Davis TR. The prevalence of degenerative arthritis of the base of the thumb in post-menopausal women. J Hand Surg [Br]. 1994;19: 340-1.

Enrollment of the first patient in a prospective, observational study of ProxiFuseTM Hammertoe Compression System

10th September 2015

Cartiva, Inc. announced enrollment of the first patient in a prospective, observational study of its FDA-cleared ProxiFuseTM Hammertoe Compression System (“ProxiFuse”). This multicenter post-market study will further demonstrate the safety and effectiveness of ProxiFuse for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe and mallet toe.

(Alpharetta, GA, September 10, 2015) – Cartiva, Inc., a developer of innovative solutions for the treatment of cartilage damage, osteoarthritis and other musculoskeletal conditions, announced enrollment of the first patient in a prospective, observational study of its FDA-cleared ProxiFuseTM Hammertoe Compression System (“ProxiFuse”). This multicenter post-market study will further demonstrate the safety and effectiveness of ProxiFuse for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe and mallet toe. The first study patient was successfully treated by John Maskill, MD of Orthopaedic Associates of Michigan at the Metro Health/OAM Surgery Center in Grand Rapids, Mich.

Hammertoes are permanent and often painful deformities of the second, third or fourth toe that cause the toe to bend at the middle joint instead of pointing forward. Surgical correction of hammer toe deformities is one of the most commonly performed forefoot procedures. One routine procedure is straightening and fusing the joint, in which the ends of the bone are cut and aligned. Pins, screws or other implants are used to keep the toe straight while the bone ends heal together. The innovative ProxiFuse device is designed to provide optimal fixation, compression and stability following the procedure.

“Despite the number of new hammertoe implants that have been introduced in recent years, there is limited clinical evidence supporting their use,” said Timothy J. Patrick, president and chief executive officer of Cartiva. “The initiation of this observational study represents our commitment to provide foot and ankle surgeons and their patients with meaningful clinical data to make informed treatment decisions.”

Study Design

The study is a prospective, multicenter observational study that will enroll a minimum of 70 patients at six sites throughout the United States. Study assessments will be performed at baseline and at two weeks, six weeks, three months and six months after the surgical procedure. Outcomes will be collected and measured using the validated National Institutes of Health Patient Reported Outcome Measurement Information System (PROMIS). The primary endpoint for the study will evaluate the six month post-surgery change from baseline in the PROMIS Pain Interference computerized adaptive test (CAT) score. Secondary endpoints will include change from baseline in PROMIS Pain Interference CAT and PROMIS Physical Functioning CAT at two weeks, six weeks and three months after surgery, time to return to normal shoe wear and postoperative adverse events that require a return to the operating room.

About Cartiva, Inc.

Based in Alpharetta, Ga., Cartiva, Inc. develops and markets innovative solutions for patients with osteoarthritis, cartilage damage and other musculoskeletal conditions. Cartiva’s venture investors include New Enterprise Associates, Windham Venture Partners and Domain Associates. Additional information is available on the company’s website at www.cartiva.net.

Cartiva MOTION study results presented by Judy Baumhauer at the AOFAS 15th July 2015

15th July 2015

This study won the MANN award for best clinical study of the year at the AOFAS meeting

(The prestigious Roger A. Mann Award is given in recognition of the outstanding clinical paper presented at the AOFAS Annual Meeting)

To read a copy of the abstract Dr. Baumhauer submitted, click here

In brief the study demonstrated that Cartiva patients can expect durable pain reduction and functional improvement as with fusion, but with a statistically significant improvement in range of motion and a quicker return to function and activities of daily living. The overall study endpoint was met and non-inferiority to arthrodesis was demonstrated.

THE STATISTICS

79% reduction in pain at 2 years!
110% improvement in activities at 2 years!
30% increase in range of motion at 2 years!
23 minute faster surgery than fusion (40% faster)!

Cartiva Announces Positive Final Data from its Cartiva SCI Pivotal Trial for Great Toe Arthritis

16th July 2015

(Alpharetta, GA, July 16, 2015) – Cartiva, Inc., a developer of innovative solutions for the treatment of cartilage damage, osteoarthritis and other musculoskeletal conditions, announced today that it has successfully met the primary endpoint of its pivotal (Phase III) randomized controlled trial evaluating the safety and effectiveness of Cartiva Synthetic Cartilage Implant (SCI) for the treatment of osteoarthritis of the first metatarsophalangeal (MTP) joint, the most common arthritic condition of the foot. The objective of the MOTION study, which involved 197 patients treated at 12 centers, was to establish non-inferiority of Cartiva SCI compared to fusion.

Joint fusion is the historical standard of care for the treatment of advanced arthritis in the great toe. While fusion provides durable pain relief, it does so by eliminating joint motion with plates or screws and requires a lengthy recovery period to allow the bones to fuse. The study demonstrated that Cartiva SCI patients can expect durable pain reduction and functional improvement as with arthrodesis, but with a statistically significant improvement in range of motion and a quicker return to function and activities of daily living.

The data was presented this morning at the Annual Meeting of the American Orthopaedic Foot and Ankle Society by Judith F. Baumhauer, MD, Associate Chair of Academic Affairs and Professor, Division of Foot and Ankle Surgery, Department of Orthopaedic Surgery at the University of Rochester and Principal Investigator for the MOTION study. Dr. Baumhauer’s abstract entitled Prospective, Randomized, Multi-Centered Clinical Trial Assessing Safety and Efficacy of a Synthetic Cartilage Implant versus First Metatarsophalangeal Arthrodesis in Advanced Hallux Rigidus was awarded the prestigious Roger A. Mann Award, given in recognition of the outstanding clinical paper presented at the meeting. Nominated studies are selected by the AOFAS Program Committee from blind review of abstracts submitted for consideration for the scientific program. The award, established in 1994 by Dr. Mann's fellows, is presented to the senior author. “These positive results from the MOTION study validate the work of our company and the surgeons who played a critical role in evaluating this new therapy,” said Tim Patrick, President and CEO of Cartiva. “Seeing these positive results from our rigorous study honored at North America’s premier Foot & Ankle surgeons’ meeting is a significant milestone for our company.”

Study Design

The MOTION study was a randomized, prospective study for MTP arthritis conducted at 12 sites in Canada and the United Kingdom where all patients were followed for 24 months. Patients were randomized 2:1, Cartiva implant to arthrodesis (joint fusion), the historical standard of care for reducing the debilitating pain associated with osteoarthritis of the MTP joint in the great toe. The primary endpoint for the study was a composite of three study outcomes – pain as measured by a Visual Analog Scale (VAS), function as measured by the Foot and Ankle Ability Measure (FAAM) Sports sub-scale score, and absence of key safety events. Secondary endpoints include great toe range of motion, VAS pain and return to function as measured by the FAAM Activities of Daily Living Score.

The individual subject’s outcome was considered a success if all of the following pre-specified criteria were met: (1) improvement from baseline of ≥ 30% as measured by the VAS; (2) maintenance of function from baseline as measured by the FAAM sports score; and, (3) absence of major safety events and subsequent secondary surgical interventions.

Study Results

The analysis of effectiveness was based on the Primary Analysis Population: 132 randomized Cartiva subjects, and 65 arthrodesis subjects. The proportion of successes in each group was determined and the difference (Cartiva minus arthrodesis) and one-sided 95% confidence interval for the difference between treatment groups was calculated.

Utilizing the primary analysis of intent-to-treat (ITT), which includes all randomized subjects utilizing last observation carried forward (LCOF) for missing data, 79% (104/132) of the subjects in the Cartiva arm met the definition of success compared to 62% (40/65) of subjects in the arthrodesis control arm, demonstrating non-inferiority (p<0.0001).Utilizing the modified intent-to-treat (mITT) study population, which includes all randomized and treated patients utilizing LCOF for missing data, 80% (104/130) of the patients in the Cartiva arm met the definition of subject success compared to 80% (40/50) of subjects in the arthrodesis control arm, demonstrating non-inferiority (p=0.0075).

The analyses of secondary efficacy demonstrate a change that is statistically and clinically meaningful for both treatment groups for all secondary endpoints evaluated. Cartiva subjects demonstrated a quicker return to function as evidenced by a statistically significant improvement over arthrodesis at 6 weeks in FAAM Sports and SF-36 Physical Function scores. The improvements in pain and function experienced by both Cartiva and arthrodesis subjects were durable over the course of the MOTION study (24 months). Cartiva subjects showed a 79% improvement in VAS pain scores and 110% improvement in FAAM Sports Scores at 24 months that well exceeded the minimal clinically important difference (MCID). The incidence of secondary surgical interventions (11%) for the Cartiva subjects and (12%) for the Arthrodesis subjects was comparable and the small incidence of Cartiva subjects requiring removal were easily and successfully converted to arthrodesis. During the course of the study, there were no clinically important radiographic findings such as wear debris or osteolysis in the Cartiva group as reported with other historic implants such as silicone, plastic or metal devices.

About Osteoarthritis of the first MTP Joint

Also known as hallux rigidus, osteoarthritis of the first MTP joint is the most common site of osteoarthritis (OA) in the foot, affecting one in 45 Americans over the age of 50, or approximately 2 million people. The MTP joint, which serves the function of pushing the foot away from the ground when walking, can become painful and stiff when affected by arthritis, leading patients to make adjustments to their movement that can have an adverse impact on other joints or lead to a more sedentary lifestyle. The current standard of care for moderate to severe osteoarthritis of the first MTP joint is arthrodesis, a procedure involving removal of cartilage, bone resection and fusion of the joint using plates and screws. The main advantage of this procedure is that it is a permanent correction and usually successful in the elimination of the arthritis pain. The major disadvantage is the restriction of movement of the big toe and the resulting limitations on certain daily activities, sports and footwear. Cartiva SCI, made from polyvinyl alcohol (PVA) is designed to replace the damaged cartilage surface. Through a proprietary manufacturing process, Cartiva SCI is designed to mimic the properties of natural cartilage.

About Cartiva, Inc.

Based in Alpharetta, Ga., Cartiva, Inc. develops and markets innovative solutions for patients with osteoarthritis, cartilage damage and other musculoskeletal conditions. Cartiva’s venture investors include New Enterprise Associates, Windham Venture Partners and Domain Associates. Additional information is available on the company’s website at www.cartiva.net.

Cartiva Announces First Human Implant of ProxiFuse™ Hammertoe Compression System

8th June 2015

(Alpharetta, GA, June 8, 2015) – Cartiva, Inc., a developer of innovative solutions for the treatment of cartilage damage, osteoarthritis and other musculoskeletal conditions, announced that the first human implant of its ProxiFuse™ Hammertoe Compression System (“ProxiFuse”) was performed last week by Judith F. Baumhauer, M.D., at the University of Rochester Medical Center’s Sawgrass Surgery Center. The FDA-cleared ProxiFuse system is an innovative solution for patients requiring fusion of the lesser toes for hammertoe, claw toe and mallet toe deformities.

Hammertoes are permanent and often painful deformities of the second, third or fourth toe that cause the toe to bend at the middle joint instead of pointing forward. Surgical correction of hammer toe deformities is one of the most commonly performed forefoot procedures. One routine procedure is straightening and fusing the joint, in which the ends of the bone are cut and aligned. Pins, screws or other implants are used to keep the toe straight while the bone ends heal together. ProxiFuse is designed to provide optimal fixation, compression and stability following the procedure.

“While multiple fixation methods have been used to achieve a stable correction, ProxiFuse addresses some limitations that have existed with implants in the past,” said Dr. Baumhauer, Associate Chair of Academic Affairs and Professor, Division of Foot and Ankle Surgery, Department of Orthopaedic Surgery at the University of Rochester. “Placement of the ProxiFuse was accomplished in a quick, simple surgical procedure. The unique design of the device allows for compression across the joint, providing a noticeable, rigid fixation of the joint, just what we hoped to achieve. We’ll follow the patient’s progress over the coming months using a validated patient reported outcome instrument (PROMIS), and we look forward to the patient telling us how she feels about her hammertoe correction with ProxiFuse.”

“Hammertoes are a very significant problem, affecting one-third of the general population and leading to approximately 600,000 annual surgical implant procedures in the United States alone,” said Timothy J. Patrick, president and chief executive officer of Cartiva. “We believe the innovative suture-lock design of the ProxiFuse offers unique compressive capabilities and other advantages to existing methods of digital correction.”

About Cartiva, Inc.

Based in Alpharetta, Ga., Cartiva, Inc. develops and markets innovative solutions for patients with osteoarthritis, cartilage damage and other musculoskeletal conditions. Cartiva’s venture investors include New Enterprise Associates, Windham Venture Partners and Domain Associates. Additional information is available on the company’s website at www.cartiva.net.

Cartiva, Inc. Announces Submission of Final Module of PMA Application for Cartiva SCI

14th May 2015

Cartiva, Inc., (Company) a developer of innovative products for the treatment of cartilage injuries, osteoarthritis and other musculoskeletal conditions, announced today that it has submitted the final module of the pre-market approval (PMA) application for its Cartiva® Synthetic Cartilage Implant (SCI) to the U.S. Food and Drug Administration (FDA). The final module, which covers the clinical results from the MOTION trial evaluating the safety and effectiveness of Cartiva SCI for the treatment of osteoarthritis at the base of the great toe, completes the Company's PMA application for the product. Results from the MOTION study have been accepted for presentation at the July Annual Meeting of the American Orthopaedic Foot and Ankle Society (AOFAS).

“The completion of our PMA submission is the most significant milestone in the Company's history and is the culmination of many years of dedicated research,” said Tim Patrick, President and Chief Executive Officer of Cartiva, Inc. “This is the largest and most rigorous FDA trial ever completed for this clinical condition. We look forward to working with FDA to bring the first synthetic cartilage product to market.” Mr. Patrick concluded, “We are also very excited about the upcoming presentation of our clinical results at the AOFAS meeting, and the opportunity to educate this preeminent group of surgeons on the clinical benefits of Cartiva SCI.”

The MOTION study involved enrollment of 236 patients at 12 centers in Canada and the United Kingdom. The trial was designed to determine the safety and efficacy of Cartiva SCI in comparison to arthrodesis (fusion) for reducing the debilitating pain associated with osteoarthritis in the great toe. Patients were randomized 2:1 to either Cartiva SCI or arthrodesis. The primary endpoint for the trial is a composite evaluation of pain, function and safety.

About Cartiva SCI

Cartiva SCI is comprised of a proprietary polyvinyl alcohol (PVA) hydrogel designed to mimic natural cartilage. PVA is a synthetic polymer prepared by the hydrolysis of polyvinyl acetate and has been used in medical device applications for over 20 years. A patented manufacturing process enables Cartiva, Inc. to customize the PVA hydrogel to meet defined functional requirements. The physical properties of Cartiva SCI, including the water content, compressive properties and low coefficient of friction, are similar to natural cartilage. Along with its ability to withstand physiologic loading, the Cartiva implant’s properties make it an ideal design for the replacement of damaged articular surfaces. Additionally, relative to other alternatives, Cartiva SCI minimizes the amount of bone that needs to be removed from the patient.

About Cartiva, Inc.

Based in Alpharetta, Ga., Cartiva, Inc. develops and markets innovative solutions for patients with osteoarthritis or cartilage damage. Additional information is available on the Company’s website at www.cartiva.net.

Cartiva, Inc. Closes $8.5 Million Financing - Expands Board with Appointment of Eric Stookey

11th May 2015

(Alpharetta, GA, May 11, 2015) – Cartiva, Inc., (Company) a developer of innovative products for the treatment of cartilage injuries and osteoarthritis, today announced that it has secured $8.5 million in an oversubscribed Series D financing led by New Enterprise Associates (NEA) and with participation by new investor Windham Ventures Partners.

Proceeds from the financing are expected to fund the Company through PMA approval of its Cartiva Synthetic Cartilage Implant following the Company’s previously announced submission of the PMA application to FDA last month. The proceeds will also support the post 510(k) clearance clinical evaluations of the Company’s ProxiFuse Hammertoe Compression System and its GRIP Study evaluating Cartiva SCI in the treatment of osteoarthritis at the base of the thumb.

“We are grateful for the continued support of NEA, one of the premier venture capitals firm in the world, and welcome the addition of Windham Venture Partners, which builds on the strength of our investors,” said Tim Patrick, President and CEO of Cartiva, Inc. “Our ability to raise capital from such quality investors is a testament to the significant progress we have made in establishing the clinical benefits of our synthetic cartilage treatment. The results from our MOTION Study were accepted for presentation at the July Annual Meeting of the American Orthopaedic Foot and Ankle Society. We are excited to share the results of this large, randomized clinical study to Foot and Ankle surgeons this summer in Long Beach.”

The Company also announced that Eric A. Stookey had joined the board of directors earlier this year. Mr. Stookey is Chief Operating Officer of OsteoRemedies, LLC, a company with the first FDA-cleared modular system for two-stage revision of infected hip and knee total joints. Prior to joining OsteoRemedies earlier this year, Mr. Stookey had a nearly 20-year career at Wright Medical Group, Inc., most recently serving as President of the Extremities & Biologics division. Mr. Stookey, who earned his Masters of Business Administration degree from Christian Brothers University and his Bachelor of Science degree in Business from Indiana University, currently serves on the board of Amedica Corporation (Nasdaq:AMDA), a biomaterial company focused on silicon nitride ceramics.

“We are delighted to have Eric join the Cartiva Board of Directors,” said Mr. Patrick. “With deep knowledge and years of experience in sales channel development, strategic planning and launching new and innovative orthopedic medical devices, his appointment strengthens the executive leadership team and adds significant operational and commercial expertise.”

About Cartiva, Inc.

Based in Alpharetta, Ga., Cartiva, Inc. develops and markets innovative solutions for patients with osteoarthritis, cartilage damage and other musculoskeletal conditions. Cartiva recently announced completion of the MOTION Study, a 236 patient, randomized, prospective study of the Company’s synthetic cartilage implant for the treatment of osteoarthritis of the great toe. Additional information is available on the Company’s website at www.cartiva.net.

About NEA

New Enterprise Associates, Inc. (NEA) is a global venture capital firm focused on helping entrepreneurs build transformational businesses across multiple stages, sectors and geographies. With nearly $17 billion in cumulative committed capital since inception, NEA invests in technology and healthcare companies at all stages in a company’s lifecycle, from seed stage through IPO. The firm's long track record of successful investing includes more than 200 portfolio company IPOs and more than 320 acquisitions. www.nea.com.

About Windham Venture Partners

Founded in 2006, Windham Venture Partners is a New York City based venture capital firm focused on healthcare technology, with a particular emphasis on medical technology (devices and diagnostics) and digital health (the intersection of healthcare and information technology). Windham seeks to invest in and partner with companies that are commercializing game-changing technologies to serve unmet needs in order to improve the lives of large numbers of patients and yield robust returns for its investors. www.windhamvp.com.

Cartiva Announces 510(k) Clearance for ProxiFuse Hammertoe Correction System

7th January 2015

(Alpharetta, GA, January 7, 2015) – Cartiva, Inc., (the “Company”) a developer of innovative solutions for the treatment of cartilage damage, osteoarthritis and other musculoskeletal conditions, announced today that it has received 510(k) clearance for its ProxiFuseTM Hammertoe Correction System (“ProxiFuse”). The ProxiFuse system, specifically developed for hammertoe fusion, is used for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe and mallet toe.

The ProxiFuse system combines several unique features into a single device. Tiny Nitinol anchors on each side of the joint are secured into the bone, connected by a strong, self-locking suture fiber. Once tightened, the ProxiFuse system is designed to deliver continuous compression across the joint to be fused. A small PEEK body provides rigidity across the fusion site. PEEK, which is radiolucent, allows clinicians to monitor the healing progress with X-ray images, a process that can be obscured by standard radiopaque metal implants.

Hammertoes, deformities of the second, third or fourth toe that cause the toe to bend at the middle joint instead of pointing forward, are one of the most common deformities of the lesser toes. One of the more common surgical procedures to treat this condition is fusing the joint, in which the ends of the bone are cut and the toe is straightened. Pins, screws or other implants are used to keep the toe straight while the bone ends heal together. In the United States, approximately 600,000[1] annual surgical implant procedures are performed to treat hammertoes. While multiple fixation methods have been used to achieve a stable correction, the most common method has traditionally been the use of a pin-like device known as a Kirschner wire, or “K-wire.” K-wires have been associated with complications including broken hardware, loosening, bending, migration and pin tract infection. Furthermore, patient dissatisfaction can be high as the K-wire protrudes from the tip of the toe during the four to six week healing process.

“We are very excited to announce the clearance of the ProxiFuse, the first intramedullary hammertoe implant designed to maintain continuous bone to bone contact through an innovative suture locking system,” said Timothy J. Patrick, president and chief executive officer of Cartiva. “We believe our system resolves many of the shortcomings of existing products, such as fixation and stability, and could provide an attractive option for patients suffering from this painful condition.”

About Cartiva, Inc.

Based in Alpharetta, Ga., Cartiva, Inc. develops and markets innovative solutions for patients with osteoarthritis, cartilage damage and other musculoskeletal conditions. Cartiva recently announced completion of the MOTION Study, a 236 patient, randomized, prospective study of the Company’s synthetic cartilage implant for the treatment of osteoarthritis of the great toe. Cartiva’s primary investor is New Enterprise Associates. Additional information is available on the Company’s website at www.cartiva.net.

Company Contact:
Peter Pizzo
Chief Financial Officer
Cartiva, Inc.
770- 754-3800

Cartiva Announces Completion of Multicenter Trial of Synthetic Cartilage Implant for Osteoarthritis in the Great Toe

13th November 2014

Study is largest randomized, prospective clinical trial for osteoarthritis of the first metatarsophalangeal (MTP) joint

Cartiva, Inc., a developer of innovative solutions for the treatment of cartilage damage and osteoarthritis, announced today that all scheduled two-year follow up patient visits have been completed in the MOTION study, its multicenter clinical trial evaluating the safety and effectiveness of Cartiva Synthetic Cartilage Implant (SCI) for the treatment of osteoarthritis of the first MTP joint. The MOTION study represents the largest prospective, randomized clinical study performed to date for this clinical condition.

“The completion of the MOTION study is an important milestone for the Company and our technology that puts us one step closer to a potential new alternative for patients with osteoarthritis of the first MTP joint,” said Timothy J. Patrick, president and chief executive officer of Cartiva. “We have commenced final data analysis and look forward to presenting the results next year.”

“Cartiva SCI has the potential to be a game-changer for those suffering from the debilitating pain of this condition but who wish to maintain motion in their joint,” said Judith F. Baumhauer, M.D., Associate Chair of Academic Affairs and Professor, Division of Foot and Ankle Surgery, Department of Orthopaedics at the University of Rochester and Principal Investigator of the MOTION study. “The MOTION study was a very well designed study conducted by leading foot and ankle surgeons in Canada and the United Kingdom, and should provide us a wealth of clinically significant data on this promising technology.”

In April 2014, the Food and Drug Administration agreed to a modular review process for Cartiva’s premarket approval (PMA) application for Cartiva SCI. The Company has submitted three of the five planned modules, and will submit the final module, including the data from the MOTION study, in the second quarter of 2015.

Study Design

The MOTION study, which completed enrollment in June 2012, is a 236 patient, randomized, prospective study conducted at 12 sites in Canada and the United Kingdom where patients were followed for two years. Patients were randomized to receive a Cartiva implant or arthrodesis (joint fusion), the current standard of care for reducing the debilitating pain associated with osteoarthritis of the MTP joint in the great toe. The primary endpoint for the study is a composite evaluation of three study outcomes – Pain as measured by a Visual Analog Scale (VAS), function as measured by the Foot and Ankle Ability Measure (FAAM) Sports sub-scale score, and absence of key safety events. Secondary endpoints include great toe range of motion, VAS pain and return to function as measured by the FAAM Activities of Daily Living Score.

About Osteoarthritis of the first MTP Joint

Also known as hallux rigidus, osteoarthritis of the first MTP joint is the most common site of osteoarthritis (OA) in the foot, affecting one in 45 Americans over the age of 50, or approximately 2 million people. The MTP joint, which serves the function of pushing the foot away from the ground when walking, can become painful and stiff when affected by arthritis, leading patients to make adjustments to their movement that can have an adverse impact on other joints or lead to a more sedentary lifestyle.

The current standard of care for moderate to severe osteoarthritis of the first MTP joint is arthrodesis, a procedure involving removal of cartilage, bone resection and fusion of the joint using plates and screws. The main advantage of this procedure is that it is a permanent correction and usually successful in the elimination of the arthritis pain. The major disadvantage is the restriction of movement of the big toe and the resulting limitations on certain daily activities, sports and footwear. Cartiva SCI, made from polyvinyl alcohol (PVA) is designed to replace the damaged cartilage surface. Through a proprietary manufacturing process, Cartiva SCI is designed to mimic the properties of natural cartilage.

About Cartiva, Inc.

Based in Alpharetta, Ga., Cartiva, Inc. develops and markets innovative solutions for patients with osteoarthritis or cartilage damage. Cartiva’s primary investor is New Enterprise Associates. Additional information is available on the Company’s website at www.cartiva.net.

Company Contact:
Peter Pizzo
Chief Financial Officer
Cartiva, Inc.
770- 754-3800

Peer-reviewed article published in European Review for Medical and Pharmacological Sciences

12th December 2013

Cartiva Inc. announce a peer-reviewed article published European Review for Medical and Pharmacological Sciences 2013; 17: 3031-3038 edition on Dr. Sciarretta’s long-term knee patients. This is the first long term data on the knee and extremely useful to the continued development of Cartiva® (SCI)