Belluscura Ltd., the global medical device company which provides premium proprietary medical devices at affordable prices, has successfully concluded a private placement to raise US $1.5m (“Private Placement”).
Background to Belluscura
Belluscura (belluscura2.wpengine.com) was established in the UK in December 2015 to provide premium proprietary medical devices at affordable prices, to address part of the global unmet need for inexpensive, superior medical devices. Belluscura will seek to achieve this goal by acquiring, then manufacturing and selling, proprietary medical devices deemed to be non-core or undervalued by leading medical device companies on an on-going basis.
In line with this strategy Belluscura acquired the exclusive licenses to manufacture and sell three medical products from Stryker Corporation, a leading medical technology company.
The devices are:
- Slyde™, a lightweight stretcher designed for use in emergency evacuations of multi-story structures.
- Passport®, a surgical trocar designed as a camera port for use in laparoscopy (keyhole surgery).
- SNAP II™, a level of consciousness monitor for use during surgical procedures requiring general anesthesia.
These three devices are protected by a comprehensive intellectual property portfolio of 19 issued and pending patents and industrial designs. They have received US 510(k) regulatory clearance where necessary and have already recorded commercial sales revenue for Stryker. In addition, Passport has been awarded a CE Mark for distribution in the EU. Belluscura intends to commence sales of Passport and Slyde in the third quarter of 2016 and SNAP II by the end of 2016.
Belluscura plans to subcontract the manufacturing of SNAP II, Passport and Slyde with the intention to sell these devices through external sales channels at affordable prices globally with a focus on the US, Europe, India and China. The targeted customers include hospitals and clinics, where they are intended for use by anesthesiologists, laparoscopic surgeons and emergency respondents, among others. The directors of Belluscura believe that the Company has the potential to achieve profitably in due course, as most of the development and regulatory costs of these devices have already been incurred.
In addition, Belluscura intends to commercialize a patented technology relating to the non-invasive measurement of glucose in saliva for the treatment of diabetes – Saliva Glucose Measurement Technology (“SGMT”). This technology is licensed from and was developed by Arizona State University.
Belluscura plans to acquire additional developed medical products which have already achieved regulatory clearance or approval, or require limited additional regulatory clearance or approval, and are deemed to be non-core by leading medical device manufacturers. Furthermore, Belluscura will also endeavor to identify and acquire undervalued proprietary technologies in the medical space that require limited investment to reach commercialization.
Belluscura has an experienced executive management team with significant expertise in the medical devices industry that covers a broad spectrum of disciplines in business, law, medicine and technology.
Further details on Belluscura’s products and management team are set out at the end of this announcement.
The Private Placement
The proceeds of the Private Placement are currently intended to be applied as follows:
- Regulatory, safety and quality expenses for medical products, including CE Marking and certification for European sales.
- Implementing product manufacturing and acquiring initial stock.
- Acquisition of additional medical products; and working capital purposes.
Commenting on the private placement, Robert Rauker, CEO, said: “We are excited to have closed the private placement for Belluscura. We believe that Belluscura has significant potential with its capable and experienced management team, compelling products and its business model of providing premium, proprietary medical devices at affordable prices through the acquisition of non-core assets from leading medical device companies.”
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Further Information on Belluscura’s Products and Management Team
This product is a level of consciousness monitoring system that can be used by anesthesiologists to make therapeutic adjustments of sedatives and anesthetic agents to a patient receiving general anesthesia.
Monitoring a patient’s level of consciousness during general anesthesia is thought to add clinical value for the following reasons:
- It allows for reduced post-operation recovery time.
- It reduces the probability of awakening during a procedure.
- It can reduce the effects associated with high levels of anesthesia.
The Directors believe that the SNAP II monitoring system has the following clinical benefits:
- The complete monitoring system is portable, allowing four hours of battery operation from one charge and requiring minimal space in a busy surgical setting.
- It is believed by the Directors to be the only level of consciousness monitoring system which evaluates both high and low frequency EEGs, creating its unique “SNAP Index” measurement. A peer-reviewed publication in the British Journal of Anesthesia from 2006 indicates that SNAP II is more sensitive to unintentional awareness than certain competitor products on the market.
SNAP II has patent protection in the US.
This product is a disposable trocar for use as a laparoscopic access device.
The Directors believe that laparoscopy as a surgical process provides clinical value as:
- The smaller incisions from laparoscopy generally provide for faster recovery and lowers the risk of infection.
- The process can reduce hospital stay and use of hospital resources.
- The process is associated with greater patient comfort and satisfaction.
The Directors believe that Passport’s key product advantages are:
- Its disposable nature.
- Its good safety record.
- Its multiple modalities, i.e. its blade-less and bladed modes.
- Its positioning as, to the best of the Directors’ knowledge, the only non-da Vinci® 8.5mm trocar available for use on the S and Si robotic surgery platforms.
Passport has patent protection and received 510(k) clearance for its sale in the US and has CE Marking approval.
Slyde is a compact sled for evacuating injured or physically challenged people easily up and down stairs during an emergency, when other means of evacuation become unavailable or overloaded. Slyde comes in two sizes for individuals up to 500lbs and up to 800lbs. Additional complementary goods are available including a protective sleeve to cover up to 5 Slydes, a rope belay system to assist in lowering the patient down stairwells, and a “firebox” for storing the belay system in the stairwell.
In the US, Slyde is a Class I (exempt) device and does not require regulatory clearance or approval. It is classified as a hand carried stretcher, subject to FDA regulation 880.6900. Additionally, Slyde is GMP exempt in the US. Until its acquisition by Belluscura, Slyde was being sold in the US, Canada and India. In Europe, Slyde is classified as a Class I product although it has not been registered with a Competent Authority in order to obtain CE Marking, for which a technical file will need to be prepared and registered with a Competent Authority. Finally, a Declaration of Conformity to the MDD 9/42/EEC will need to be written prior to affixing the CE Marking. Slyde has patent protection in the US, Canada and the UK.
In 2016, the Board plans to expand sales of Slyde to hospitals worldwide and high-rise commercial buildings that need emergency evacuation equipment. The Board also plans to target the commercial facility safety market, for the emergency evacuation of physically challenged individuals in the case of fire or terrorist attacks.
Executive Management Team
Robert (Bob) Rauker, Chief Executive Officer
Bob is a senior management executive with a demonstrable track record in the medical device sector. Over his extensive career Bob has been involved in the valuation, acquisition and sale of multiple medical devices. Bob has served as Head of Medical Device & Life Sciences Group for Acacia Research Group (NASDAQ) in the role of Sr. VP, where he built the medical device business to $30 million in revenue. Previously he served as Global Chief IP counsel for Synthes Inc. (SIX) and Boston Scientific (NYSE) Endoscopy, both multibillion dollar companies, where he managed the medical products acquisition and licensing transactions along with other senior management roles.
Bob has a bachelor’s degree in mechanical engineering and an MBA from the University of Massachusetts and a juris doctorate from the New Hampshire School of Law. Additionally, he is a registered patent attorney, a named inventor on twelve US patents and pending applications in the medical device sector and joint developer of a commercially sold spine product.
Michael N. Van Hoy, Chief Operating and Product Sourcing Officer
Michael has significant experience in developing strategic partnerships for sourcing medical product manufacturing and ensuring their quality and safety. He served as staff scientist for Becton Dickinson & Company, Technology Licensing Manager for Abbott Laboratories and Director of Business Development for Metabolon Inc. Michael received a Ph.D. in biochemistry from the University of Texas at Austin, an MBA with honours from the University of Chicago and bachelor’s degree in biochemistry, molecular and cell biology from Northwestern University.
Stephen C. Appelbee, Head of Global Sales
Stephen is a senior medical device and pharmaceutical industry executive with over 35 years’ experience across a broad range of areas in both large and small corporations operating in both the private and public financial markets. His M&A track record includes the successful acquisition of Biohealth Italia srl, Ashbourne Pharmaceuticals Ltd., of which he was Chairman, and the formation of the joint venture Puredel Ltd with Natreon, Inc., as well as the sale of CM&D Pharma Limited to Nestlé SA. He has served as CEO of ScienceWorks Ventures plc, Flint Pharma, CM&D Pharma Ltd. and Maelor plc (now known as IS Pharma Ltd). Previously Stephen has worked for Glaxo Holdings plc, as an international product manager for Zantac, and he currently serves as a Non-Executive Director for PlasMedica Technologies Limited, Pulmeze Limited and PhageWorks Limited.