Film Dressing & Creams
Peripheral & Coronary Stents
We are developing Gene-Delivering Medical Devices to Promote and Accelerate Wound Healing. Encapsulated baculoviruses that have been modified to carry a human gene are coated onto a medical device. The platform can be applied in different ways.
Gene-Delivering Film Dressings & Creams to Treat Diabetic Foot Ulcers
Globally by 2035 there will be an estimated 600 million diabetics, and approximately 25% of these will at some point suffer from Diabetic Foot Ulcers (DFUs). Furthermore, it has been calculated the total cost in the USA alone to DFUs equates to >$300 billion per year.
Treatment of DFUs is one of the major unmet needs in clinical medicine today.
The global market size is estimated to be US$ 17 billion.
The major course of management is education, preventing infections and antibiotic treatment. If these fails, amputation is required and in 2015 some 55,000 amputations were performed due to DFUs costing US$ 5 billion.
Over counter treatments are just cold-creams and are NOT CLINICAL PROVEN.
Regranex (approved by the US-FDA) is very expensive, of very limited use and had been given a BLACK BOX.WARNING.
MangoGen’s approach is to market a gene-delivering film-dressing and a cream/gel to treat diabetic foot ulcers. The active ingredient of Regranex is the growth factor PDGF-beta.
MangoGen’s approach is to deliver the gene for the growth factor PDGF-beta.
This will be a more targeted and safer approach, with only the tissue in and around the wound expressing PDGF-beta.
MangoGen has already shown that film-dressings can be coated with encapsulated viable baculoviruses and the product is stable at room temperature for >24 weeks.
The next steps are to demonstrate efficacy in animal studies allowing regulatory filings to initiate human clinical trials.
Our approach is unique
Gene-Delivering Sutures to Promote & Accelerate
Wound Healing & Prevent Scar Tissue Formation
The function of a suture is to hold tissue together so that the healing process can occur and reduce potential infections.
Sutures act as a passive material that may promote scar tissue formation. Furthermore, disruption of local blood vessels within the wound decreases oxygen (hypoxia) and nutrients hindering re-modeling.
Ideally, a suture should promote and accelerate the wound healing process as well as preventing scar tissue formation.
MangoGen is developing an array of suture products that are coated with gene-delivering baculoviruses. The gene (or genes) delivered will: i) promoting and accelerate wound healing by delivering a gene that will promote angiogenesis in and around the wound, and ii) a gene that will prevent scar tissue formation.
Our approach is unique
Gene-Delivering for Peripheral & Coronary Stents
The current stents choice today is Drug-Eluting Stents (DES) but they ignore the underlying problem of cellular damage endothelium incurred by stent deployment.
The endothelial cell layer provides a natural anti-thrombogenic surface on the inner portion of the heart and blood vessels and consequences of a stent-damaged endothelium can be debilitating and even life threatening. The current clinical paradigm is to alleviate the downstream consequences of the wound. This is achieved by employing stents that release pharmaceuticals that reduce the risk of excessive scar tissue formation in and around the stent, coupled with long-term prescription of drugs that prevent thrombosis.
We need a stent that can repair the damaged endothelium whilst preventing both in-stent restenosis and thrombosis. '
There is also a need to develop efficient below the knee stents used to treat Peripheral Arterial Disease (PAD).
MangoGen’s has developed a coronary (and peripheral) stent that rapidly repairs the wound to the inner lining of a healthy blood vessel (endothelium) elicited by stent deployment. Once the stent is deployed the biodegradable coating rapidly dissolves releasing the modified baculoviruses, and due to the proximity to the target cells, the baculovirus enter the local cells before serum deactivation. After entry, the human gene is subsequently transcribed, and the desired growth factor is released promoting the accelerated repair of the endothelium.
(See Paul et al (2013) Nature Scientific Reports 3, 2366)