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RMS Regrow gets FDA India nod for cell therapy product

The Ministry of Health and Drug Controller General of India (DCGI) have granted market authorisation for Regenerative Medical Services Regrow’s Chondron, India’s first cell therapy product that is indicated for treatment of cartilage defects of the joints.

Chondron uses the body’s own autologous cartilage cells which are cultured and multiplied for 3-4 weeks at Regrow’s Cell Processing Centre. The cultured cells are then implanted into the patient’s damaged joint leading to new cartilage regeneration, avoiding the need of early joint replacement.

“We are immensely happy with the FDA approval for Chondron ACI. We are the first in the country and fourth in the world to achieve this FDA approval,” said Chief Executive Officer and Managing Director of RMS Regrow Yash Sanghavi.

“We are creating new age cartilage regeneration procedure which optimises the chances of healing due to the use of the body’s own cells. Patients can now expect a care free future with this treatment and RMS Regrow offers a perfect PEN solution (P-Permanent, E-Easy, N-Natural biological) to the patients,” he added.

The advantages associated with Chondron ACI include regeneration of cartilage instead of replacing the entire knee; · minimally invasive personalised treatment; increased quality of life; resumption of complete physical activity, including of professional sports; cost effectiveness; and joint preservation providing long term relief.

“Today, knee pain is the most common ailment in every household. Osteoarthritis is the most prevalent form of arthritis, affecting over 15 million adults every year, with the number likely to escalate to over 60 million by 2025,” said Company Chief Scientific Officer and Executive Director of RMS Regrow Satyen Sanghavi.

“Knee implants are expensive and the recovery of the cartilage is not fast. Chondron ACI has 97 per cent success rate with fast recovery, as observed in over 4-5 lakh cases performed worldwide. RMS Regrow is proud to announce the FDA approval for Chondron ACI and it is proprietary and patented by RMS Regrow,” he added.

Chondron ACI is recommended for patients of 15-65 years age group. It is imperative for a patient to go through rehabilitation process for a minimum of six weeks. The rehabilitation process is performed in the guidance of the doctor and the physiotherapist. There is also medical insurance reimbursement available with Chondron ACI.

In India, Osteoarthritis is the most prevalent form of arthritis, affecting over 15 million adults every year. There is no specific treatment proven as yet that can reverse the joint damage caused by osteoarthritis.

There are about 4-5 lakh of knee, ankle, shoulder and hip replacement revision surgeries being performed in India annually and the number is only going up every year.

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