Concept Medical Inc.
TypePrivate
IndustryMedical technology
Founded2008
FounderManish Doshi
HeadquartersTampa, Florida, USA
Area served
Globally
Key people
Kiran C Patel (Chairman)
SubsidiariesEnvision Scientific
Websitewww.conceptmedical.com

Concept Medical Inc. (CMI) is a multinational medical devices company that develops and manufactures drug-eluting stents (DES) and drug-coated balloon (DCB), which are used in the treatment of coronary and peripheral artery diseases.[1][2]

The company is known for the development MagicTouch, the world’s first sirolimus-drug coated balloon (SCB), which was granted the Breakthrough Device designation and IDE approvals by the USFDA for the treatment of superficial femoral arteries (SFA).[3][4]

MagicTouch SCB has been widely studied globally in multiple clinical trials, including the Eastbourne registry, Nanolute, and ongoing trials like the Transform 1, Transform 2, Ginger, Titan, and Hybrid Bifurcation DEB.

In an article published by The Economic Times, Dr. Martin Leon, founder of the Cardiovascular Research Foundation and leads the IDE trials, said that the "FDA approval for the MAGICAL-SV clinical trial using the MagicTouch sirolimus-covered balloon with nanolute technology is a significant milestone in their ongoing effort to find the best therapy for managing patients with small vessel coronary obstructive disease."[5]

The Indian Government awarded the company the National Technology Award for its innovations in the cardiovascular space and drug delivery devices. It's among India's top ten pharmaceutical firms, Asia's largest producer of DCB and DES, and one of the top three medical device companies in India by market share.[6] In 2021-22, the company was the largest medical device exporter from India and given an award by the President Ram Nath Kovind.[6] The International Book of Records named it the Fastest Growing Medical Device Company in the Indian Stent Market.[7]

Originally founded in Cleveland, OH, the company relocated to San Jose, California, and is now headquartered in Tampa, Florida. Apart from its U.S. presence, Concept Medical has offices in the Netherlands, Singapore, and Brazil.[8]

History

Concept Medical, founded by Manish Doshi, a textile engineer without a medical degree, started its operations in Cleveland, OH. Before entering the medical device sector, Doshi was involved in chemical trading and international laser machining. He initially worked in the textile industry at Mafatlal Industries in Navsari and later started an import-export business supplying materials to the paint industry in Gujarat.[1]

In 1998, angioplasties became more popular than bypass surgeries. These small spring-like components, crucial for heart surgeries, weren't being produced by any Indian company at the time. Manish gathered a team of engineers to focus on improving the design of cardiovascular devices, particularly coronary stents in India. The company became a pioneer in developing nanotechnology-based applications for drug delivery.[9]

The company imported machinery, invested $10 million over seven years, and developed a marketable coronary stent.[1]

Following this, major players like Johnson & Johnson entered the competition, significantly reducing blockage percentages from 40 to less than 10, in some cases, none at all. While J&J used polymer for their stents, CMI pioneered the development of biodegradable stents, which became a standard in procedures. The company started participating in clinical trials, conducting studies in the Netherlands upon receiving CE approval for their stent.[1]

However, in the 2000s, Boston Scientific and Angiotech Pharmaceuticals filed a €25 million patent infringement lawsuit against them. Despite losing the case, Manish only had to pay €1,400 since his product was still in the clinical trial phase and commercialization in Europe was prohibited.[1]

In October 2018, Indian cardiologist and businessman Kiran C Patel invested $60 million in the company for clinical studies on cardiac devices to replace stent.[8]

In February 2022, Concept Medical received IDE approvals for the Magic Touch PTA to treat below the knee peripheral arterial diseases (PAD) and MagicTouch SCB to treat coronary in-stent restenosis (ISR) in September 2022 from the US Food and Drug Administration (FDA).[2]

The company received its third IDE approval from the USFDA for its ‘Magic Touch SCB’ drug-coated balloon (sirolimus-coated). The IDE approval was for the treatment of small vessels (SV) in coronary arteries.[10][2]

Operations

Headquartered in Tampa, Florida, Concept Medical operates in 80 countries, including Asia, Europe, the Middle East, and other global regions.[11] The company has two facilities in Surat and the capacity to produce two million drug-eluting balloons and 1.5 million drug-eluting stents annually.[1][12] All the products are manufactured at the Indian subsidiary, Envision Scientific (ESPL).[13]

Concept Medical holds 96 patents granted globally in countries such as the US, China, Japan, Europe, India, and Australia.[14]

Products

Abluminus

Abluminus features sirolimus coating on both the stent and balloon, utilizing a biodegradable polymer matrix for continuous drug release. This is employed for coronary artery blockage treatment without the need for external scaffolds. The company claimed that clinical results demonstrated a re-blockage rate of 2.4%, in contrast to 10-14% for other products.

MagicTouch

MagicTouch was developed for patients with blockages in small arteries where stents aren't suitable. It uses a sirolimus-coated balloon that delivers the drug in 60 seconds, releasing it over 30 days. The main challenge in developing MagicTouch was the instability and weak binding properties of sirolimus, which makes it difficult to stick to the balloon and lowering its bioavailability. This is different from paclitaxel, which has strong binding properties but is debated due to concerns about its toxicity among cardiologists.

MagicTouch is currently the only sirolimus-coated balloon globally approved with CE certification.[4] It is the most clinically studied sirolimus-coated balloon for peripheral artery disease (PAD) treatment[15][16] and has been the subject of ongoing clinical studies in the United Kingdom, Italy and Brazil.[4][17][18]

References 

  1. 1 2 3 4 5 6 Ubhaykar, Rajat (28 December 2016). "Magic Touch". outlookbusiness. Retrieved 2023-12-10.
  2. 1 2 3 "Concept Medical receives 3rd IDE approval from USFDA for MagicTouch-Sirolimus Coated Balloon". www.biospectrumindia.com. Retrieved 2023-12-11.
  3. ↑ Dava, Parag (2023-05-26). "Concept Medical receives 4th IDE approval from USFDA for its MagicTouch Sirolimus Coated Balloon to treat SFA". The Times of India. ISSN 0971-8257. Retrieved 2023-12-11.
  4. 1 2 3 "Concept Medical's Receives FDA Approval for the MagicTouch-Sirolimus Coated Balloon". DAIC. 2023-05-12. Retrieved 2023-12-11.
  5. ↑ "Concept Medical receives 3rd IDE approval from US FDA for MagicTouch-Sirolimus-coated balloon - ET HealthWorld". ETHealthworld.com. Retrieved 2023-12-11.
  6. 1 2 "We aim to emerge as a global leader in life-saving devices, says Manish Doshi, founder of Concept Medical". The Economic Times. 2022-05-19. ISSN 0013-0389.
  7. ↑ "Fastest Growing Medical Device Company in Indian Stent Market (2019-2020)". internationalbookofrecords.com. Retrieved 2023-12-11.
  8. 1 2 "Miami medical company will move to Tampa after Dr. Kiran Patel's $60 million investment". Tampa Bay Times. Retrieved 2023-12-10.
  9. ↑ "Dr. Manish Doshi: Playing A Pivotal Role In Renovating The Global Medical Device Industry". www.ceoinsightsindia.com. Retrieved 2023-12-11.
  10. ↑ Parmar, Vijaysinh (2020-09-26). "Surat firm's innovation to sweeten diabetics' life". The Times of India. ISSN 0971-8257. Retrieved 2023-12-11.
  11. ↑ "We aim to emerge as a global leader in life-saving devices, says Manish Doshi, founder of Concept Medical". The Economic Times. 2022-05-19. ISSN 0013-0389.
  12. ↑ "Concept Medical India sets up Rs 80 crore unit in Surat SEZ". The Times of India. 2020-09-26. ISSN 0971-8257.
  13. ↑ "Envision Scientific receives IGBC gold certification for its factory". The Times of India. 2023-05-17. ISSN 0971-8257.
  14. ↑ "Concept Medical secures $60m financing to develop IDE for Sirolimus-coated balloon". NS Medical Devices. 2018-10-10. Retrieved 2023-12-11.
  15. ↑ "A novel nanocarrier sirolimus-coated balloon for coronary interventions: 12-Month data from the Nanoluté Registry". Researchgate.
  16. ↑ Tang, Tjun Y.; Soon, Shereen X. Y.; Yap, Charyl J. Q.; Chan, Sze Ling; Tan, Ru Yu; Pang, Suh Chien; Lee, Shaun Q. W.; Yap, Hao Yun; Choke, Edward T. C.; Tan, Chieh Suai; Chong, Tze Tec (2020-10-27). Kirchmair, Rudolf (ed.). "Early (6 months) results of a pilot prospective study to investigate the efficacy and safety of sirolimus coated balloon angioplasty for dysfunctional arterio-venous fistulas: MAgicTouch Intervention Leap for Dialysis Access (MATILDA) Trial". PLOS ONE. 15 (10): e0241321. Bibcode:2020PLoSO..1541321T. doi:10.1371/journal.pone.0241321. ISSN 1932-6203. PMC 7591053. PMID 33108398.
  17. ↑ "Tampa company with Dr. Kiran Patel as chairman wins key designation for devices that reduce risk of heart blockages". 2019-05-03. Archived from the original on 2019-05-03. Retrieved 2023-12-10.
  18. ↑ "Drug-coated balloons emerging as better alternative to stents: Italian cardiologists". ETHealthworld.com. Retrieved 2023-12-11.
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