$GBSXD - BIOTECH MARIZYME - ACTIVE PATENTS / PENDING PATENTS & KRILLASE PRODUCT:
Patents:
Multiple Applications: WO 2008/070698 A1 (June 12, 2008), Also EP2007/086455, US20110135625
Multiple Applications: US 7,947,270 B2 (May 24 2011)
Wound Healing: WO 2013/149809 A1 (October 10, 2013)
Thrombolysis (Pending): EP 15004350.2 (December 4, 2015)
Dental Health: US 12/741,781 (December 30, 2010) Also Published as: WO 2009/060013 A2,A3 and EP
2217266 A2
European Approvals:
TUV: Class III Medical Device for Wound Care (July 11, 2005)
Filing Contacts: Renata Materna, rmaterna@rmc-rheinfelden.de
2. Krillase® Applications
A. Chronic Wound Care:
Chronic non-healing wounds require special care and often last many month and years or may never fully
heal. The increased prevalence of these types of wounds is caused by growth in diabetes and longer lifespans. Many of these wounds can result in amputation if treatments cannot control the growth of necrotic tissue. To treat these wounds often requires grafting which may not be effective if the wound isn’t properly cleansed of necrotic tissue prior to the graft. We estimate grafting is only successful about 35% of the time. Krillase makes grafting possible by achieving up to a 90% efficacy rate for the grafting process. Krillase has achieved Class III Medical Device classification.
Wound Care Monetization Strategy:
We expect to license this application of our technology first. Our partner expects to complete a facility and intends to sell directly to hospitals as part of their grafting programs. The hospitals are reimbursed $8,500 by the insurance companies for the entire grafting procedure and we expect to receive approximately $1,500 per procedure from the hospital leaving $7,000 for the hospital to cover their expenses, the doctors, and profit margins. Total market size in Germany could be as much as $6 Billion for Krillase as a result
B. Thrombolysis:
Krillase will completely dissolve the thrombus by breaking down the fibrins and can be applied in any timeframe. The proteolytic enzymes in Krillase can breakdown any fibrous cap on any age of clot. This is
extremely useful if the patient hasn’t been able to reach an acute care center within the required 3-6 hours for tPA and TNK. Also, Krillase works in 1/10th the time dissolving complex aged clots in 3 minutes as opposed to 30 minutes thus saving more heart or brain tissue from ischemic death. Most importantly, due to the mechanism of action of Krillase, there is no chance of bleed out and it would be acceptable to use it in most patient populations, even children.
Thrombolysis Monetization Strategy:
Marizyme intends to apply for a Rare Pediatric Voucher and
complete studies for application of Krillase in children. The Rare Pediatric Disease Voucher is transferable and of the 13 or so that have been issued most have been sold to large pharmaceutical companies for $125M to $350M. We intend to complete a pediatric stroke study and license Krillase to Roche/Genentech for human use and then sell the Voucher to the highest bidder.
3. Marizyme Business Model
Quote:
We intend to follow a model of licensing out our promising technologies for individual applications to larger players who bring competitive advantages that our shareholders will benefit from including distribution, industry certification, unique market experience, brand or assistance in completing clinical studies. We intend to grant exclusive licenses to our technology either worldwide or on a larger territory basis for specific applications. In exchange we will seek ownership in our partner when feasible, milestone payments, and ongoing royalties. Our partners will be expected to make investments in the final product
and to package, market and distribute that product. We believe this approach will allow us to pursue several opportunities concurrently and we will begin with the first three applications described within this summary.
Nicholas P. DeVito, 54 – CEO Mr. DeVito
has 32 years of experience in finance, engineering and operations in a variety of industries including oil & gas, telecommunications, alternative energy, manufacturing and consumer products. Most recently he served as Director of Accounts at Synchronoss Technologies, Chief Operating Officer for Xtreme Oil & Gas (OTCBB:XTOG) successfully reorganizing the company and completing the filings to begin public trading. Mr. DeVito has served VP of Business Development and as CEO of several subsidiaries in Tellium (NASDAQ:ZHNE), a highly successful telecommunications equipment manufacturer that sold $200M of optical switching products and completed an IPO raising $400M. He consulted to several private consumer products companies acting to improve operations and grow sales. Finally, Nick spent 14 years at AT&T and Bell Laboratories. He has a BSEE and MSEE from Columbia University and an MBA in Management from New York University.
