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RMS regrow get FDA India approval for Cell Therapy Product

RMS regrow get FDA India approval for Cell Therapy Product
Mumbai: The Ministry of Health, India and DCGI have granted Market Authorization for India’s First Cell Therapy Product of India that is Chondron® ACI by Regenerative Medical Services Regrow. Chondron ACI is indicated for treatment of cartilage defects of the joints. It 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.
Speaking on this, Chief Executive Officer & Managing Director, RMS Regrow, Mr. Yash Sanghavi said, “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. We are creating new age cartilage regeneration procedure which optimizes 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”.
Company Chief Scientific officer & Executive Director, RMS Regrow, Mr.Satyen Sanghavi said, “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. Knee implants are expensive and the recovery of the cartilage is not fast. Chondron ACI has 97% 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.”
Advantages of Chondron ACI
  • Regeneration of cartilage instead of replacing your entire knee
  • Minimally invasive personalized treatment
  • Increased quality of life
  • Resume complete physical activity , including of professional sports
  • Cost Effective
  • Joint preservation providing Long term relief

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. Hence the objectives of Osteoarthritis management are to reduce the level of pain, reduce inflammation, slow cartilage degradation, improve function and reduce disability.

There are about 4-5 lakhs of knee, ankle, shoulder and hip replacement revision surgeries being performed in India annually and the number is only going up every year. An artificial knee will only last about a decade before wearing out. So if you are under 60, you will have to undergo several more ‘revisions’ in your lifetime. Chondron ACI helps for better solution with effective and fast term results. Similar nature products for Chondron ACI have been available in use since 2001 in countries such as USA, Europe including UK & South Korea and being reimbursed by their respective Health agencies.

Source: self
1 comment(s) on RMS regrow get FDA India approval for Cell Therapy Product

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  1. Sorry.. please clarify what is meant by FDA India.
    the article says DGCI and govt of India..

    Is there an entity known as FDA india.. has the DGCI been renamed ..or has FDA a franchise in India

    Please do clarify otherwise retract this misleading title .

    Dr Chandran