SOLANA BEACH, Calif., Aug. 27, 2020 /PRNewswire/ -- Healeon, a wholly owned subsidiary of Bimini Health Tech, announced today it received FDA 510(k) clearance for its novel blood separation system for Platelet Rich Plasma (PRP) preparation, the Healeon Duet (BK200449).  

Healeon's new Duet technology is exclusively distributed by Suneva Medical, under the tradename Amplifine, in the Aesthetic Marketplace.  "We, at Suneva Medical, are thrilled that Amplifine PRP has obtained 510K clearance and believe that this further strengthens our portfolio and our leadership position as the essential source for facial regenerative aesthetic treatments.  We look forward to providing a game-changing technology to our provider partners looking to offer customizable PRP to their patients" said Pat Altavilla, Chief Executive Officer of Suneva Medical.

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The Healeon Duet enables safe, quick, and easy separation of blood components into customizable platelet concentrations. Designed for use within the practitioner's office, the launch of the Healeon Duet system creates a new product category focused on delivering a tailored concentration approach for patient treatment applications, and allows:

• Small blood draw (25ml) into a closed system.

• Provides operators full control of all desired parameters to fine-tune the approach depending on the application, offering 5 platelet derived solutions in a single technology:

  • Low Density PRP (LD PRP)

  • High Density PRP (HD PRP)

  • Leukocyte Rich PRP (LR-PRP)

  • Leukocyte Poor PRP (LP-PRP)

  • Platelet Rich Fibrin (PRF)

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"The Healeon Duet overcomes one of the most challenging parts of platelet preparation -- customizing concentration levels in controlled dosages for specific procedure types in a single platform," said Jeff Greiner, CEO of Healeon and CCO of Bimini Health Tech. "The Duet provides the operator total control over the concentration process, post platelet isolation."

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"The Duet was developed with ease of use in mind while still providing the operator flexibility in the preparation process, with the ability to produce several desired platelet preparations in a single technology. With FDA clearance of the Duet, we have expanded our blood separation and PRP product portfolio to broaden the use across medical specialties." Added Mr. Greiner, "PRP preparation is not a one-size-fits-all for all applications.  It's important that the clinician has the appropriate technology to support the proper treatment applications. It's now easier for clinicians to feel confident they are providing their patients the highest quality PRP for each desired treatment application".

ABOUT BIMINI HEALTH TECH and HEALEON®

Bimini Health Tech is a global leader in the medical aesthetics and regenerative market. The Bimini Health Tech portfolio includes Healeon®, Puregraft®, Dermapose®, and Kerastem®.  The company develops and commercializes products that are elegant in their simplicity, yet impactful and proven in their aesthetic and therapeutic benefit. Since 2013, they have been developing innovative products to provide premium aesthetic care options to consumers and physicians alike.

Healeon® is dedicated to paving the way for regenerative solutions by providing innovative medical devices for autologous, point-of-care treatments.  Healeon has rapidly emerged as a major player in the regenerative medicine market.  Specifically, Healeon's technologies offer easier and safer solutions that provide unparalleled cell and protein concentrates designed to meet individual practice and patients' needs.

www.biminihealthtech.com

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BIMINI HEALTH TECH ACQUIRES HEALEON MEDICAL, INC.

Combination Creates a Global Leader in the Regenerative Product and Therapy Market

SOLANA BEACH, Calif. and NEWBURY PARK, Calif., June 16, 2020 /PRNewswire/ -- Bimini Health Tech announced today it has acquired Healeon Medical, Inc.  Healeon represents an excellent addition to Bimini’s family of autologous  products, continuing its mission of discovering, developing, and acquiring technologies and therapies to unlock the power of the human body.

Healeon designs, develops, manufactures, and markets medical devices for extracting, processing, concentrating, and sizing various living human tissues and cellular composites for aesthetic and therapeutic applications. The company emphasizes preserving cellular activity to assist in restoring or enhancing function at the tissue-specific level. Healeon's products include: the signature HD PRP system, optimizing the capture of platelet concentrates at the point-of-care; Healeon LTM System, a sterile, closed-loop platform for micro-fragmenting adipose tissue—including the Evulse Adipose Micronizer to precisely fragment and maintain the viability of the cell and tissue structure; and the SURE-Loc disposable cannula,  for consistent removal and injection of fat tissue.  Healeon’s future pipeline includes of a family of products focused on enhancing and simplifying PRP and adipose-based processing.

“The acquisition of Healeon brings tremendous value to Bimini’s current product portfolio.  Healeon’s commercially available PRP products and adipose product pipeline allows Bimini to offer a comprehensive set of autologous (cells or tissues obtained from the same individual) therapies to physicians globally,” said Brad Conlan, CEO of Bimini Health Tech. “The Healeon technology is complemented by a team bringing years of medical device sales and marketing experience to Bimini.  The combination of our two companies further establishes Bimini as a global leader in the regenerative medicine market.”

“Healeon is thrilled to become part of the Bimini portfolio, continuing our mission of bringing novel technologies to the global regenerative medicine marketplace.  The combined experience coupled with the breadth of products, positions Bimini Health Tech to be a formidable leader for years to come.” said Jeff Greiner, CEO of Healeon Medical, Inc.

ABOUT BIMINI HEALTH TECH

Bimini Health Tech is a global leader in the regenerative product and therapy market. The company develops and commercializes products that are elegant in their simplicity, yet impactful and proven in their aesthetic and therapeutic benefit. Since 2013, they have been developing innovative products to provide premium aesthetic care options to consumers and physicians alike. The Bimini Health Tech portfolio includes the brands Healeon®, Puregraft®, Dermapose®, and Kerastem®.

ABOUT HEALEON MEDICAL, INC.

Healeon Medical, Inc. (HMI) is a CA-based corporation dedicated to paving the way for regenerative solutions by providing innovative medical devices, clinical expertise, and support for autologous, point-of-care treatments.  Healeon Medical has rapidly emerged as a major player in the regenerative medicine market with a vertically integrated platform for regenerative medicine therapy.  Healeon actively innovates new technologies for tissue acquisition and isolation with the intent to further simplify the point-of-care process for the clinician interested in providing regenerative medicine therapy.  Healeon's technologies and techniques offer easier and safer solutions that isolate unparalleled cell and protein concentrates designed to meet individual practice and patients' needs.

Learn more at www.biminihealthtech.com

Healeon Medical, Inc., the leader in regenerative solutions, is proud to announce their new High-Density Platelet Rich Plasma (PRP) Series.  In response to the requests of their customers for a more versatile and higher volume product, Healeon has developed a PRP solution that is the best available answer for all of the ever-expanding uses for which platelet rich plasma is currently being employed.  As with all Healeon Medical regenerative products, the new HD PRP is designed for point-of-care treatments in the physician’s office. This HD PRP offers the clinician a variety of options, concentrations and volumes in producing platelet-rich plasma.

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The new HD PRP series features an array of PRP tubes and accessories - 12cc, 15cc and 30cc collection tubes - all capable of producing a more potent PRP, in denser concentrations and higher volumes, suitable for any application where PRP is indicated. 

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“Through 2 years of research and development, we created a product line that provides the clinician the ease of use and the flexibility that truly represents the best value for their money,” says Jeff Greiner, CEO of Healeon Medical.  “Healeon HD PRP is easy to use, has a high platelet capture rate and the flexibility to produce the entire spectrum of above-base-line concentrations needed.  Realizing not all PRP is created equal, and with science catching up to the bedside, Healeon has made it easier for clinicians to feel comfortable in choosing the right PRP product for the desired application.”

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Healeon HD PRP, through its simple 3-step process, is one of the easiest and most reliable systems available on the market.  The range in sizes provides versatility and options for the clinician to select a tube based on the desired concentration range for the indication being treated. 

SAN DIEGO, Jan. 3, 2019 /PRNewswire/ -- Suneva® Medical, Inc., is proud to announce two exciting new partnerships intended to shape the future of regenerative aesthetics. Building on the success of Bellafill, its flagship regenerative biostimulatory product and the longest lasting dermal filler on the market, Suneva Medical has signed two new partnerships with Healeon Medical, Inc and Puregraft, LLC.

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"The combination of our world class commercial organization and these unique and innovative Aesthetic products strategically positions us for long term growth as a leader in the regenerative aesthetic market," says Preston Romm, CEO, Suneva Medical. "These new products will add significant breadth to Suneva's product portfolio."

Healeon Medical of Newbury Park, California develops and commercializes next generation innovative medical devices and offers clinical expertise, and education to medical professionals in the regenerative medicine market. Healeon has signed a partnership with Suneva Medical for certain markets on their proprietary, cutting-edge PRP technology, featuring an innovative high platelet capture design and a long-term exclusive relationship on Healeon's next generation technologies arriving to the aesthetics market mid-2019.

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"Healeon Medical has a concentration on the growth of regenerative medicine, making Suneva Medical a great partner as it continues to lead this promising area of aesthetics," says Jeff Greiner, CEO of Healeon Medical.

Based in Solana Beach, California, Puregraft LLC is the world's leading fat grafting company. In 15 minutes or less, the Puregraft products provide surgeons with purified fat for reinjection. Puregraft is devoted to developing fat based technology focused on the emerging regenerative aesthetics market. Suneva Medical has a distribution partnership with Bimini for certain markets on their proprietary Puregraft fat grafting system for use within the regenerative skin and body care industry and an exclusive relationship on their next generation technology scheduled to launch in early to mid-year 2019.

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"Suneva Medical is a seamless connection for our Puregraft products and its next generation technology. We look forward to growing the relationship and working together to shape the global aesthetics market," says Brad Conlan, CEO of Puregraft.

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To learn more about Suneva Medical and upcoming news from the aesthetics company, please visit www.SunevaMedical.com.

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About Suneva Medical, Inc.
Suneva Medical is a privately‐held aesthetics company focused on developing, manufacturing and commercializing novel, differentiated products for the aesthetic markets. The innovative aesthetics leader markets Bellafill®, the only dermal filler on the market that is approved by the U.S. Food and Drug Administration for the correction of nasolabial folds and moderate to severe, atrophic, distensible facial acne scars on the cheek in patients over the age of 21 years old. The company markets Bellafill® in the U.S., Canada, Hong Kong, Korea and Mexico. For more information, visit www.sunevamedical.com.

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About Healeon Medical, Inc.
Healeon Medical, Inc. (HMI) is a CA-based privately held corporation focused on developing innovative medical devices, clinical expertise and support for point-of-care regenerative treatments. Healeon has rapidly emerged as a major player in the regenerative medicine market with a vertically integrated platform for regenerative medicine therapy. Healeon actively innovates new technologies for tissue acquisition and isolation, with the intent to further simplify the point-of-care process for the end-user.  Healeon's technologies and techniques offer easier and safer solutions that isolate unparalleled cell and protein concentrates designed to meet individual practice and patient's needs.  For more information, visit www.healeonmedical.com

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About Puregraft, LLC.
Puregraft, LLC is a wholly owned subsidiary of Bimini Technologies, a privately held company focused on the cash-pay, aesthetic marketplace. The Bimini portfolio also includes Kerastem, LLC (www.kerastem.com) and Aurastem, LLC.  Today, Bimini's products are distributed in over 60 countries. 

SEPTEMBER 2015

Dr. Robert Alexander, Chief Clinical Scientific Officer with Healeon Medical, Inc., was recently recognized by his peers being voted as one of the Top 10 Physicians in the World for Stem Cell Innovations.  This prestigious honor is a direct result of Dr. Alexander’s years of research and contributions to the stem cell field.  Members of this select group were voted on by their colleagues around the world and are revered as the experts in this ever-evolving field.  Their contributions and scientific research have led to many scientific breakthroughs and have enhanced the safety profile by with bio-cellular treatments are performed. 

Jeff Greiner, CEO of Healeon Medical says, “We are very excited for Dr. Alexander.  His years of experience in the bio-cellular field have contributed to many of the protocols used in the clinical setting today.  Dr. Alexander’s continued dedication to this field has increased the standard of care and furthered science to allow for bio-cellular procedures to be performed appropriately around the world.  It is wonderful he is now being recognized by his peers for such contributions.”

AUGUST 2015

Healeon Medical, Inc. is proud to announce the addition of Dr. Robert Alexander as its Chief Clinical Science Officer.  Dr. Alexander brings years of research and clinical-based experience to the Healeon team.  Dr. Alexander will be working closely with Healeon for the development and implementation of IRB clinical trials, along with more defined protocols of use with Healeon’s CENTRIcyte™ 1000 isolation system.

Dr. Alexander holds doctorates in Medicine and Dentistry, and is the author of multiple publications and book chapters on the subject of aesthetic, reconstructive and cranio-maxillofacial surgery, of which he is recipient of many awards and recognitions.  His presentations on the use of high-density platelet-rich plasma concentrates to sports medicine; prolotherapists; and orthopedic-regenerative medicine practitioners, led to important contributions in use of adipose-derived stem/stromal cells with HD PRP for musculoskeletal, wound healing, and regenerative applications. 

 “We at Healeon Medical are very excited to have Dr. Alexander join our team.  His years of experience in the bio-cellular field bring an immediate impact to Healeon, and allow us to further provide an increased standard-of-care for parties looking to perform point-of-care cellular treatments”, said Jeff Greiner, CEO of Healeon Medical.  

With this new relationship, Healeon Medical is setting the standard for which companies in the bio-cellular space should follow.  Now with Dr. Alexander involved, Healeon Medical will be looking to launch a series of IRB clinical trials beginning this summer. 

SEPTEMBER 2014

Healeon Medical, Inc. is paving the way for a broad array of regenerative solutions, which up until now, were not readily available in your physician’s office.  Healeon Medical does this by providing innovative medical devices, clinical expertise and support for autologous point-of-care treatments, which are typically not found available in a clinical setting, to physicians and surgeons across the country.  They are able to do this by leveraging its years of experience in the medical device and surgical fields to develop a product mix designed to meet the demands set forth by physicians who want to be able to perform these procedures in a clinical setting at their point-of-care.  What does this mean for the patient?  No longer having to go outside the country to obtain these procedures; patients are able to receive regenerative treatments and therapies with confidence in their physician’s office or clinic.

Healeon’s flagship product, the CENTRIcyte™ 1000, makes point-of-care regenerative processes a reality.  This new, state-of-the-art, all-in-one isolation device simplifies the isolation of cells from all tissue sources using a semi-automatic method.  This eliminates the need for laboratory personnel, and allows for simple, consistent and reproducible results.  It allows clinicians to maximize cell counts and viability from the smallest of samples at the point-of-care.  The CENTRIcyte™ 1000’s proprietary specimen kits allow for easy transferring of specimens through a closed system, which minimizes the chance of cross contamination and reduction of cell viability due to environmental influences.  The CENTRIcyte™ 1000 will meet any clinician’s adipose, bone marrow and peripheral blood processing needs. Your physician and their staff will be able to perform the tissue and cell extraction, processing and therapeutic treatments, without the need to send out samples for processing or bring in additional staff. 

Dr. John Laura says, “Having the ability to perform the cell isolation and perform the treatments right in my own clinic is not only a benefit for us to control costs and save time, but it allows my patients to receive their treatments from me and my staff, without having to travel outside the US or to another facility.  This gives my patients the peace of mind of being in a familiar setting; and allows us to administer their treatments easily and safely.  Healeon has made this possible with their CENTRIcyte™ 1000 device.  My staff loves the ease of use, and my patients love that the procedure takes only 2-3 hrs.”