News

Import license; submitted in India. The company filed an application for the registration of RegenoGel in India

ICRS 2022 Berlin World Congress – Abstract Submission.

Procore has submitted an abstract to participate in a large-scale congress of a unique worldwide forum for cartilage regeneration and joint preservation.

Procore extends distribution of Regenogel-OSP to private clinics and medical centers in Israel.

RegenoGel-OSP is an autologous version of RegenoGel with an added layer of personalized properties. RegenoGel-OSP (On Site Plasma) combines high molecular weight hyaluronic acid (HA) with the patient’s own plasma.

Distribution agreement; Vietnam. Signed agreement with a local distributer to import the product to Vietnam following Product Registration and import license to the territory.

Quality certificate for Regenogel Production facility extended. ISO 13845 accreditation granted to Procore’s manufacturing facility, enabling production of RegenoGel. The company also received a Free Sale Certificate for exporting RegenoGel worldwide.

Distribution agreement for the Ukraine. Procore signs a distribution agreement with a multinational distribution company with presence in the Ukraine towards registration of Regenogel with the official Ukrainian Medicines Authority.

Procore signs a Distribution agreement with a local Chinese company, in collaboration with the largest pharmaceutical distributor in China. The company has committed to complete regulatory and CFDA guided trials within 18 months and begin distributing and selling RegenoGel in greater China in the second quarter of 2022.

First publication summarizing interim results of ProCore’s Post Marketing Placebo Controlled Double Blind Clinical Study for RegenoGel and RegenoGel OSP, demonstrating superiority of RegenoGel and RegenoGel OSP treatment over placebo for patients suffering from moderate to severe knee osteoarthritis.

ProCore has signed marketing and distribution agreement for the RegenoGel line of products with LAVI partners for the Israeli market.

ProCore completes the first phase of its Multi center, Placebo Controlled Double Blind Clinical Study of RegenoGel and RegenoGel OSP, for Interim analysis of safety and efficacy.

Procore to Complete validation of its state of the art, GMP compliant cleanrooms suite for the production of RegenoGel and RegenoGel OSP.

Procore announces the launch of its new manufacturing facility in its Ness Ziona site with a fully qualified clean room suite dedicated to the production of its RegenoGel family of products.

The facility meets the highest international regulatory standards and shall allow the scale up of Procore’s production capacity to meet future developments and increasing market requirements.

ProCore was granted an extended marketing approval from the Israeli MoH to include treatment of all articular joints.

The RegenoGel line of products received extended and comprehensive approval from the Israel Ministry of Health for use by qualified medical practitioners in all medical centers and clinics to treat all joints.

Procore and the Plastic Surgery Department at Kaplan Medical Center, led by Dr. Dana Egozi, are coordinating a clinical trial to test the efficacy of RegenoGel in acute wound healing for pain control, wound infection and scar formation.

Procore initiated a new clinical trial in collaboration with five leading medical centers in Israel, including Sourasky Medical Center (Ichilov), Assaf Ha’Rofeh Medical Center, Hadassah Medical Center, Meir Hospital and Sha’arei Tzedek Medical Center. This comprehensive post-marketing trial will provide first-level evidence to support efficacy of RegenoGel in alleviating pain and restoring joint function, as well as a comprehensive comparison between the different products and their treatment protocols. Leading orthopedists and rheumatologists are taking part in the trial.

A new collaboration agreement Assuta Medical Centers includes opening dedicated laboratories at the Ramat Ha’Chayal and Rishon Le’Zion Assuta branches for preparing RegenoGel-OSP. Among the doctors prescribing RegenoGel products at Assuta Medical Centers are Dr. Gavriel Eger, Head of Orthopedics at Assaf Ha’Rofeh Medical Center; Dr. Vadim Benkovich, Director of the Joint Implementation Unit at Soroka Medical Center’s Orthopedics Department; Dr. Stefan Ben-Shoshan, a specialist in spine and joint diseases at Assuta’s Asia Medical Center; and Dr. Yiftach Ber, Head of the Endoscopic Orthopedic Unit in Assaf Ha’Rofeh Medical Center. Procore expects the collaboration make the treatment significantly more accessible for Assuta patients.

Following its first year of market experience of product efficacy and high safety profile, Israel’s Ministry of Health has expanded the indication for RegenoGel to include treatment of hip and shoulder joints. Treatment is now available throughout Israel for pain and cartilage erosion of the knees, hips and shoulders.

Following a pre Investigational Testing Authorization (ITA) meeting with Health Canada, Procore received its first clinical development plan and product designation for RegenoGel as a medical device by the Canadian authorities, with plans towards product registration and commercialization in Canada.

Procore is proud to announce the launch of a new, “off-the-shelf” version, RegenoGel-RG, a mechanically stable, non-autologous viscosupplementation solution expected to provide long-term pain relieve and restoration of joint function.

Procore is sponsoring an investigator-initiated a clinical trial at the Orthopedic Department at Kaplan Medical Center, led by Prof. Yona Kosashvili and his colleagues Dr. Tavor Hovav and Dr. Philip Rozinsky. This is the first trial of its kind investigating the potential to enhance post-surgical rehabilitation and provide long-term protection from trauma-induced osteoarthritis in young people who suffer from sports injuries, such as meniscus tears.

Procore announced a new collaboration with the Ramat Aviv Medical Center to introduce RegenoGel-OSP (On-Site Plasma) treatment, an autologous treatment for osteoarthritis of the knee. The collaboration includes establishing dedicated laboratory to prepare RegenoGel-OSP. The Ramat Aviv Medical Center is an ultra-modern facility with over 65 specialists on staff providing high quality medical services to clients.

Magen David Adom (MDA), The Israeli “Red Cross” & Procore Ltd. announced a new research collaboration for developing next generation tissue repair solutions combining Procore’s RegenoGel with MDA’s blood born cells and plasma components. Procore’s research team will cooperate and gain access to MDA’s professional support and facilities.

Procore announced the official launch flagship RegenoGel-OSP, an autologous viscosupplementation treatment for osteoarthritis of the knee. The treatment is now available in specialty clinics and medical centers throughout Israel. The launch was initiated at the Ramat Aviv Medical Center by Dr. Ron Arbel, President of the Israeli Sport Medicine Association.

The Israel Ministry of Health Medical Devices Division (AMAR) certified the RegenoGel product family for patients suffering from osteoarthritis of the knee. The medical device certification followed a set of pre-clinical and clinical trials that took place in collaboration with the Orthopedic Department of Assaf Ha’Rofeh Medical Center. The trial included patients with severe osteoarthritis who were all scheduled for total knee replacement surgery. This is an important milestone following long-term collaboration between Procore and the Orthopedic Department, under the leadership of Prof. Nachum Halperin and Dr. Gavriel Eger.