Using the natural healing properties of Buckwheat honey, combined with our advanced bioactive enhancements, SanMelix has created a product that aids in the healing of acute, chronic and minor wounds. With IP protection on our BEECure™ MGO dressing and other pending patents, co-created by a renowned Harvard trained podiatric physician, SanMelix's advanced bioactive wound care products can be used in a host of settings and situations. We have created over-the-counter (OTC) skin care products such as ointments and creams designed to help in the healing of minor burns, scrapes, radiodermatitis and more. Our products will also be used for advanced wound care healing in hospitals and rehabilitation centers, by physicians through the use of dressings and ointments.

We have a talented and world-renowned physician group who puts patient care first. Our goal is to improve the lives of patients and help speed up the healing process using the natural therapeutic properties that already exist in honey. Honey has been used in medicine since 8000 BC because of its unique healing properties and with our team of doctors and scientists, we have enhanced it through the use of broad-spectrum antimicrobials. Dr. Sabacinski developed the BEECure™ dressings to help prevent the dangerous side effects and adverse drug interactions that often arise with the use of predominantly synthetic pharmaceuticals. 

Dr. Sabacinski has been working in the wound care space for over thirty years, and he knows the patients’ needs for a product that encourages fast wound closure and provides protection from bacteria and infection. Our mission at SanMelix is to help people. We want to give caregivers, physicians, and the general public the ability to heal using a natural product that’s been used for centuries. At SanMelix, the proof is in the honey. 

With the funds raised through StartEngine, we plan to complete the testing on our products as well as prepare inventory. Our first product launch will be our OTC cosmetic line. We are in negotiations with a European company to license or purchase the CE Marked formulation for our first buckwheat honey skin care product and will use the funds to help complete this arrangement.

• 50 million people annually are affected by acute and chronic ulcerations*
• Chronic wounds affect over 5.7 million patients in the U.S. alone and are estimated to cost $20 billion annually, thus impacting the market growth positively**
• Everyday people require wound care therapies for minor cuts, scrapes, abrasions, and rashes***
• The global bioactive wound care market was valued at $6.9 billion in 2015 and is expected to grow at a CAGR of 6.3% through 2024**

Sources:

*https://www.forbes.com/sites/genemarcial/2014/02/03/overlooked-advanced-wound-care-market-catches-attention-of-healthcare-analysts-investors/#5c53948c48a3

**https://www.grandviewresearch.com/industry-analysis/bioactive-wound-care-market

***https://medbroadcast.com/condition/getcondition/cuts-and-scrapes

• Potentially dangerous side effects can occur from entirely synthetic wound care products
• There are environmental consequences to the manufacturing of chemical based products
• There are multi drug resistant super infections such as MRSA and A. baumannii*
• Skin grafts and skin substitutes require repeated application**
• There are few effective therapies for radiotherapy, laser therapy and minor thermal burns***
• Often severe wounds can result in amputations

Sources:

*https://www.reuters.com/investigates/special-report/usa-uncounted-cdc/  

**https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4775710/

***https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5677297/

• SanMelix OTC formulations would be considered a first aid antibiotic/antiseptic/antimicrobial to treat minor cuts, scrapes and burns
• In-vitro findings show that our honey formulations support the efficacy against MRSA and A. baumannii
• Buckwheat honey reduces scarring and inflammation related to radiotherapy, laser therapy and minor thermal burns
• Case studies illustrated accelerated healing and skin regeneration on severe limb threatening wounds
• Need for fewer applications of skin grafts and skin substitute when honey dressings are applied to graft site
• Studies have shown buckwheat honey has bactericidal activity against antibiotic-resistant pathogens*
• Greener product in use and in manufacturing

Sources:

*https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5326189/ 

We are focusing on the unique medicinal properties of Buckwheat Honey for tissue regeneration and accelerated healing. Our bioactive buckwheat honey formulations demonstrate intrinsic healing activity with anti-microbial additives to prevent infection. SanMelix has a patent on its BEECure™ MGO formulation and Dr. Sabacinski has co-invented 2 additional patent pending natural Buckwheat Honey BEECure™ medical devices which also demonstrated superior clinical outcomes. Studies have proven that buckwheat honey has superior medicinal properties to Manuka honey and other natural remedies. Our products also have higher standardization and broader spectrum anti-microbial activity allowing them to be used on a physician level. Buckwheat honey also has higher anti-inflammatory and anti-oxidant activities than other products currently being used. 

The anti-oxidant properties in Buckwheat honey assist in wound closure and help to stimulate the wound healing process. This means wounds are healing faster and better without the risk of further complications that could be a great hindrance to the lives of patients. The mix of Buckwheat honey with our patented formulation creates a microbial barrier to prevent life-threatening bacteria from penetrating through the dressing while it is in use. The nutrients in the honey help spur tissue regeneration because it contains large quantities of easily assailable sugars, amino acids, vitamins, specifically vitamin C. Our products are made to heal chronic and difficult to close wounds.

Our BEECure™ products can be used for a wide variety of skin irritations and advanced wound care. Because of the microbial barrier claim in our wound care dressings, they will be instrumental in the treatment and healing of:

• Ulcers, diabetic and otherwise
• Skin grafts
• Burns
• Trauma and triage
• And more!

We are working in tandem with Trauma Insight, who has formed a CRADA with the Airforce, to perform the 510(k) performance and microbial barrier testing. On the battlefield, being able to dress injuries quickly and carefully while keeping bacteria out of the wound is of the utmost importance. Right now, there's an antibiotic-resistant infection that is affecting military personnel overseas. Our dressings create a barrier that will keep the wound clean even in the harshest of conditions.

The advanced wound care MGO dressing is currently in the testing phase, and being tested by the U.S. Air Force. The radiodermatitis cream is in the testing phase for the product and packaging. All other products have not yet been created.

Although manuka honey is the most commonly used honey-based wound treatment on the market, studies have shown that buckwheat honey has superior inherent healing properties when compared to manuka honey due to its higher anti-inflammatory and higher anti-oxidant activities.  In addition, SanMelix’s advanced wound care products have been fortified with antimicrobials to ensure a higher standardized and broader spectrum antibacterial activity. Our patented formulation utilized in our AWC dressings permits SanMelix to launch the first bioactive honey dressing to make a microbial barrier claim in the U.S. Our bioactive dressing will be for any wound type of any depth and severity. The dressing will prevent biofilms from forming,  control wound odor, reduce pain and treatment time while being cost-effective and more environmentally sound. 

Additionally, there will be improved skin and tissue regeneration and debriding action. This prevents the necessity for excess skin grafts or skins substitutes, which run the added risk of infection or rejection. Studies have shown buckwheat honey has bactericidal activity against antibiotic-resistant pathogens.

The bottom line is that our enhanced Buckwheat honey dressings and ointments are making the lives of patients and doctors easier. We are here to assist in the healing process and make a painful experience as painless as possible. We have seen firsthand the need for such products as the ones we've been creating and know that our BEECure™ products are going to be a big step forward in changing the lives of many. 

Through our collaboration with our Contract Research Organization, Trauma Insight, we have been able to establish a collaboration with the Air Force in order to conduct pre-clinical research that will support the 510(k) product testing. Trauma Insight builds on the lessons learned from combat casualty care delivered on the battlefield in Afghanistan and Iraq.

We are looking to continue testing our advanced wound care products to obtain 510(k) pre-market clearance from the FDA and to continue prosecuting our other two patent pending formulation applications. We are in negotiations with a European company to distribute its existing buckwheat honey CE Mark products for radio-dermatitis and laser therapy induced skin reactions and secure our main authentic raw buckwheat honey supplier.

On top of this, we are negotiating with other GMPs to contract manufacture our skin care products. We will continue to test, research and expand our products utilizing world renown physicians and scientists.

We are thrilled about all that lies ahead for the SanMelix team and the effect our nature-based products will have on healing.

SanMelix is proud to have some of the most experienced and widely renowned minds behind our products. Dr. Kenneth Sabacinski has worked in the advanced wound care space for over thirty years. He is a podiatric physician who started his training at Harvard Medical School and Beth Israel Deaconess Medical Center in Boston. People come from all over the world to see him for treatment of limb and life-threatening wounds including diabetic-related foot ulcers.

In addition to co-founder Dr. Sabacinski, our medical team of experts includes Dr. Jason Green, D.O. Board Certified Dermatologist, and COL (ret) George E. Peoples, MD, FACS. Dr. Green is our Advisory Board Director and is currently performing product testing of our initial CE Mark skin care product for radiodermatitis. Dr. George Peoples is the founder of Trauma Insight. Through his military career as a staff surgeon at a level I trauma center and multiple combat deployments, Dr. Peoples has extensive trauma experience and has developed close relationships with some of the most prominent military and civilian trauma and critical care physicians in the country.

Diana Sabacinksi and John Kaufman also serve as directors. Diana has over 25 years of accounting experience across a swath of fields, as well as starting her career in a Big 4 CPA international accounting firm.  John Kaufman is the founder of InteSec Group Fla LLC. He also founded Be Power Tech Inc. and served as its Chairman, Director, co-patent holder, and consultant. Together, the directors boast business acumen and scientific prowess and along with partnerships with other leading researchers and scientists, SanMelix is proud to have such strong and exciting leaders at the helm.

Our skin care product line will provide honey based ointment for a myriad conditions like radiodermatitis, rashes, acne and much more. We are currently in the testing phase, running skin irritation and comparative performance tests. Our initial skin care product will be regulated under the United States Federal Food, Drug, and Cosmetic Act. The FDA OTC monograph program will use the patent pending formulations while using already recognized FDA products to enhance our creams and ointments. 

BEECure™ products can be used for or as a(an):

• Acne Treatment
• Antiseptic Bandage
• Diabetic foot cream
• Burn Care Ointment
• Radiodermatitis
• Eczema
• Eye drops
• Eczemema
• Diaper Rash
• And more!

There are over 50 million reported cases globally of patients suffering from hard-to-close wounds. 15% of these are diabetic foot ulcers that eventually lead to amputation. SanMelix BEECure™ bioactive wound care products are here to treat everything from a minor scrape to a severe wound and everything in between. Using our unique enhanced Buckwheat honey formulations fortified with microbial barriers, we are treating all types of dermal afflictions by speeding up the healing process and reducing pain and the risk of infection. 

Honey is a product that's been used all throughout history as a healing and restorative agent, and we are harnessing its natural powers and using our years of scientific and medicinal studies to enhance it. We are regulating it to make it safe for hospital use, as well selling it OTC to the average consumer. Everyone should be able to experience the benefits of the BEECure™ Buckwheat honey products. 

Our customers will include the VA & DoD, medical supply distributors, physician networks, hospitals, SNFs as well as indirect sales channel for private label/ white label for OTC opportunities. We will market directly to OTC consumers through digital marketing and social media. We are capitalizing on a market that has been desperately in need of a natural and safe product that promotes healing and tissue growth among many other benefits. 

We have a talented and world-renowned physician group who puts patient care first. Our goal is to improve patients' lives in need of healing with our innovative bioactive wound care and skin care products.