About Biomedical RGF
Our team members are focused in improving safety with the PRF-BRGF system and compliance with medical device regulations – FDA CFR 21 – before going to market in the USA. Enforcing our QMS, protocols, and logistics plan organization. Biomedical RGF’s objective is to bring the safer PRF-BRGF System to market before the end of the first quarter of 2025.
After FDA clearance, our small team of hard-working people will be hiring professionals to help us running all areas of the business including Regulatory, Management, Marketing, Logistics, Education and Research.
About Our Company
Biomedical RGF is a starter company originated by the need of a safer and compliant PRF system & supplies for patients safety and avoid doctors’ liability risks
01
The Need Found – BRGF,LLC – 2017
We saw the need for a safer PRF medical device components. The blood collection tubes for PRF devices in the market included:
a)- nonsingle patients use sterile pack blood collection tubes. Risks of contamination of PRF.
b)- Blood tubes contain a coat of silica dust and other additives that affect the blood purity, or
c) – Glass tubes that have a risk of breakage and cause injury and/or contamination.
02
The Vision – 2018
We evaluated the market and discovered that the PRF market was growing 20% to 22% yearly since 2010. We also discovered that issues a,b & c made the current devices and tubes NON-COMPLIANT with 3 laws and regulations for blood sterility, safety and blood purity.
02-1: Tubes have to be sterile in and out
02-2: Tubes shall not have any additives that affects the PRF blood purity.
02-3: Glass Tubes shall not be used unless protected with puncture-resistant material
03
The Inventions 2018-2019
We invented solutions to the noncompliance and safety issues of the current tubes in the market in 2018. The first invention was the blood collection tubes, a single-patient-use sterile pack, to comply with the FDA regulations for sterility. Later, we invented the Dual blood collection tubes to avoid the use of silica-coated tubes for blood purity and the glass tube protection regulation compliance.
04
The Planning 2018-2019
We started to work in the business plan with all projections and started to raise capital with some success. Then we started to obtain funds from a few doctors , friends and family.
Planning and working on the research for testing took many months of hard work.
05
The Testing & Regulatory 2018-2022
Performance testing for the viability of the new tubes and centrifuges was intense. Biocompatibility, transportation and sterility tests were challenging due to high costs and funds available. In 2023 we completed most tests required.
06
The Status and Future of the Market
We are working on final tests required. FDA clearance expected to be in approximately 10 months as of 4/5/2024. The PRF market continues to grow at an amazing rate and will continue growing as the bone grafts and implants market grows at a CAGR of 9.5%
Contact us:
3401 N. Federal Hwy. Suite 220
Boca Raton, FL 33431
(561) 674-6639
info@Biomedicalrgf.com
Our Amazing Team
Our team members are highly motivated to bring our unique and safe PRF-BRGF System to market . Trust in our expertise to achieve the best outcome for the final launch of the new standard of care for PRF.
President
Brigitte Cardona CDA
Brigitte has being related to healthcare for more than 4 years. She especially enjoys getting to know doctors at the conventions informing them about the PRF_BRGF System status and projections.
She is charge of investor relations and testing as coordinator, 510k documentation and QMS. The best part of her job is being part of our unique medical device with confidence and trust is its safety and compliance.
Vice-President
Dr. Claudia Santamaria
Dr Claudia Santamaria has been a healthcare provider in Florida for more than 25 years.
She was the first director of Biomedical RGF involved with the PRF-BRGF System and medical device patent registration, produnts registration and testing of the blood collection tubes and centrifuges.
Claudia enjoys spending time with her two kids and going to the gym in her free time.
Marketing & IR
Natalia Montoya
Natalia enjoys connecting with doctors and investors assisting them with any concerns or help that they need, she enjoys giving our future partners the attention and information they need. She has a charismatic personality and is always smiling.
On her free time she enjoys spending time with family and loved ones, being active and healthy at the gym.
.
Research & Education
Dr. Jannys Guerra
Dr Jannys Guerra is a skilled dental professional and member of prestigious associations. Proficient in comprehensive treatment planning, endodontics, and advanced digital dentistry, she excels in CADCAM technologies. The commitment to use PRF in most of dental extraction reflects her holistic approach to dental care. Dr Jannys is part of our research team and PRF testing.
Research & Regulatory
Dr Alvaro Betancur
Dr. Betancur underwent Sinus Lift, Implants and Bone Grafting training at the University of Miami in 1994, TMJ and Craniofacial Pain Management at University of Florida 1995, and Advanced Bone Grafting and Sinus Lift Training at Dr. Pikos’ Institute. Dr. Betancur has extensive experience in Sinus Lifts, Bone Grafting, Wisdom Teeth Surgery, and the use of Plasma and Growth Factors since 2000.
Research & Education
Dr Robert Hwang
Dr Hwang is dentist in New York with practice focused in dental implants, PRF and high tech laser therapy.
Dr Wang Gaduated from the University of Columbia school of dental surgery and has been part of the admissions committee at Columbia University.
He is part of our research and edu team,
