Orthobiologics Activity Signals Collaborations and Clinical Data Essential for Company Growth

ORTHOWORLD estimates that global orthobiologic product sales account for ~10% of the orthopaedic market’s revenue, overall. In 2016, that translated to just over $4.9 billion, an increase of 3% vs. 2015. For this year and into 2019, we’re projecting similar growth.

Supporting this growth will be patients who continue to seek non-surgical alternatives for joint repair, and continued growth in the use of synthetics and stem cell-based products. Collaborations will remain attractive in the space as companies choose orthobiologic-focused partners to get products to market, and universities partner with companies on licensing and development. Robust clinical and economic data will be a requirement for product clearance and adoption. These strategies were among our stated market observations in THE ORTHOPAEDIC INDUSTRY ANNUAL REPORT®, and activity thus far in 2017 reaffirms our stance.

We’ve compiled year-to-date activity through the second week of October 2017—M&A, collaborations, funding, data—to show how your competitors and customers have responded to market demands.

Exhibits 1 and 2 illustrate who acquired or partnered with whom so far, this year.
Exhibit 1: Merger & Acquisition Activity

Exhibit 2: Collaboration Activity

Of the 34 transactions that we’ve reported to date this year, orthobiologics were involved in eight. Exhibit 3 shows where dollars were spent.
Exhibit 3: Funding Activity

Clinical data on the cost/benefit of orthobiologic treatments is required to gain product clearance and adoption. This last section details clinical trials and studies.

Hip/Knee

Andrews Institute for Orthopaedics & Sports Medicine and the Andrews Research & Education Foundation are facilitating a randomized, multi-center Phase II U.S. FDA-observed clinical trial evaluating use of a patient’s own stem cells to regenerate knee cartilage. This is reportedly the first time that stem cells will be evaluated in a clinical trial for the ability to regenerate cartilage in massive knee cartilage injuries. The 6-year study may end early if results indicate statistical significance.

Studies indicate that Anika Therapeutics’ HYALOFAST scaffold + autologous adult MSCs present a viable option to treat knee cartilage lesions, regardless of patient age.

Phase III study results demonstrated that Anika’s CINGAL provided superior immediate and short term OA pain relief after injection vs. hyaluronic acid alone, and superior relief at 26 weeks vs. saline.

Bone Therapeutics completed patient recruitment for interim analysis in its Phase III trial of PREOB for the treatment of hip osteonecrosis.

Results from Phase I and Phase II study indicate that Histogenics’ NeoCart tissue-engineered implant is a safe, effective treatment for articular cartilage lesions through 5-year follow-up.
Spine

Results from ovine study of Bio2 Technologies’ Vitrium bioactive glass demonstrated the device’s capability to support interbody fusion.

Interim results in a Phase IIA trial with Bone Therapeutics’ ALLOB showed evidence of successful spinal fusion and statistically significant improvements at 12 months.

Burst Biologics received IRB approval for a U.S. prospective clinical study of BioBurst cellular allograft in spinal fusion.

Follow-up data from an IDE clinical trial of Cerapedics’ i-FACTOR bone graft indicated statistical superiority to autograft in ACDF.

FDA accepted DiscGenics’ Investigational New Drug Application for a clinical study of its cell therapy product candidate to treat degenerative disc disease.

Medtronic launched a long-term global clinical study to collect prospective data on INFUSE bone graft in posterolateral and transforaminal lumbar interbody fusion.

Studies suggest that a single injection of Mesoblast’s Mesenchymal Precursor Cells resulted in meaningful improvements in chronic low back pain and function that were durable for at least 3 years.

SpinalCyte announced the first injection in a clinical trial of CybroCell fibroblasts for spinal disc regeneration.
Trauma

Bone Therapeutics reported positive interim efficacy results and early conclusion of the Phase I/IIA study of ALLOB allogeneic bone cell therapy in the treatment of delayed-union fractures. Given the close relationship between the delayed-union and non-union indications, the company will also cease recruitment in the PREOB non-union trial to focus resources on ALLOB.

BONESUPPORT enrolled the first patient in the pivotal Investigational Device Exemption trial of CERAMENT G in the surgical repair of open diaphyseal tibial fractures.

Carmell Therapeutics will launch a Phase III clinical study for Bone Healing Accelerant, its first Plasma-based Bioactive Material product/indication, designed to treat fractures.

Interim results from study of PolyPid’s BonyPid-1000 bone substitute in the treatment of open tibial fractures indicate that the product met performance and safety endpoints in first patients at 6 months.
Soft Tissue Repair

MiMedx commenced a Phase III study to evaluate AmnioFix Injectable allograft vs. placebo in the treatment of Plantar Fasciitis.

Orthocell announced recruitment of the first patient in a clinical trial investigating Ortho-ATI to treat rotator cuff tendinopathy.

Six-month results from Phase I/II study indicate that RepliCel’s RCT-01 fibroblasts demonstrated product safety and clinical potential for tendon regeneration and healing.

Interim study results indicate that patients receiving Rotation Medical’s Bioinductive Implant to treat rotator cuff disease reported statistically significant improvement at six months. Earlier results indicated inducement of new tissue formation in all study participants with large and massive rotator cuff tears.
Julie A. Vetalice is ORTHOWORLD’s Editorial Assistant. She can be reached by email.