BioCeramic Therapeutics Ltd.
This article was originally published in Start Up
Executive Summary
BioCeramic Therapeutics was formed around separate regenerative medicine technologies that it believes have broad potential. First up is a strontium containing glass-based material for use as a bone filler and a coating for metal implants used in various orthopedic and orthodontic procedures. The company is also developing a nanostructured synthetic extracellular matrix that could address the regeneration of hard and soft tissues, with the potential one day to allow almost any tissue to be grown.
Smart materials for bone and tissue repair
BioIncubator Unit
Bessemer Building (RSM) Level 1
Prince Consort Road
London, SW7 2BP, UK
Phone: +44 (0)20 7594 1326
Web Site: www.bioceramictherapeutics.com
Contact: Daniel Green, CEO
Industry Segment: Biomaterials; Tissue Engineering
Business: Bioactive bone fillers and coatings, synthetic extracellular matrix
Founded: June 2006
Founders: Robert Hill, PhD (Imperial College London); Molly Stevens, PhD, CSO
Employees: 2
Financing to Date: £1 million
Investors: Imperial Innovations Inc.; Comvest Ltd.
Board of Directors: Daniel Green; Molly Stevens; Mark Rowan
Clinical Advisory Board: Justin Cobb, BMBCh FRCS MCh, Chairman
It was CEO Daniel Green’s background in venture capital that led him to see the potential in BioCeramic Therapeutics Ltd. "One of the advantages about being a venture capital investor is that you can diversify your risk. One of the problems with jumping over the fence to run a company is that you often lose that diversification. So I was looking to start a business that was robust and could withstand the occasional setback that affects so many life science companies."
He was an entrepreneur-in-residence at Imperial Innovations Group PLC, the AIM-listed technology transfer company, when he spotted two separate regenerative medicine technologies—a bioactive glass bone filler and a nanostructured extracellular matrix, and their combined potential. The breadth of the possible applications was evident to Green, and Imperial Innovations gave him the go-ahead to incorporate the new company in June 2006. "We set out to construct a company that had some of the investment characteristics of a devices company, some of the investment characteristics of a drug discovery company, and some of the investment characteristics of a platform technology company," he says.
BioCeramic Therapeutics’s core technologies were developed at Imperial College London by founders Robert Hill and Molly Stevens. The so-called generation one products are bioactive ceramics used as bone graft substitutes, orthopedic coatings and in other applications.
Bone grafts substitutes have been around since the 1970s and are used for fractures that fail to heal, usually because of the significance of the fracture size. These substitutes can be made of many materials, including bioactive glass with components that make it more bone-like, such as calcium. The area was not particularly noteworthy until Medtronic PLC came along with its bone filler, INFUSE, in 2002. INFUSE contains recombinant human bone morphogenetic protein, the genetically engineered version of a naturally occurring protein capable of initiating bone growth or regeneration. It has defined the market for enhanced fillers and is a $1 billion a year product.
Meanwhile, Stevens had observed the effects of Servier SA’s osteoporosis drug, strontium ranelate (Protelos), on bone growth and postulated that if strontium was added to the bioactive glass bone filler instead of calcium, it could also have a beneficial effect on bone growth. She was right. Not only did the strontium boost bone growth in vitro, but, serendipitously, it also made the glass more bioactive.
BCT 001 is BioCeramic Therapeutics’ first product and has completed "promising" in vitro work, says Green. Bone cells were grown on two glass disks--one made of standard bioactive glass and one of BioCeramic Therapeutics’ bioactive glass with strontium. It was observed that two to three times as many bone cells grew on the BioCeramic Therapeutics’ disk. In November 2007, an in vivo study began and, if the results are good, work could move into man this year.
BCT 002 will be a coating material for metal implants used in various orthopedic and orthodontic procedures. Currently, cement is used in some joint replacement procedures, but the cement can deteriorate relatively quickly causing problems as fragments come loose. Metal pins do a better job but the healing process can be protracted, which is not desirable in the elderly and which generates increased associated costs for patients of all ages. BCT 002 is expected to accelerate the healing process, making cementless procedures possible for more patients, especially the elderly, where excessive periods of immobility are associated with increased morbidity.
Green is confident that BioCeramic Therapeutics’ products will be readily accepted by the medical community because they are similar to the products already used, "but better." The marketing, however, to such a broad range of medical professions may prove challenging.
These first-generation products will be classified as medical devices, which could mean that one to two trials will be sufficient to obtain the EU CE mark or approval under the FDA’s Class II Device category.
BioCeramic Therapeutics’ second-generation products are "far more ambitious," according to Green. "Within BioCeramic Therapeutics in the short to medium term, you have the generation-one products that are well understood and well characterized but in the single digit, billions of dollars a year market. The generation-two products have longer time lines and higher risks, but the market value is at the high end of the tens of billions of dollars."
These products will address the regeneration of hard and soft tissues, with the potential one day to allow almost any tissue to be grown. This could have implications for heart attack or stroke patients, where damaged cardiac or brain tissue could eventually be regenerated using BioCeramic Therapeutics’ technology.
Stevens invented the technology after noticing that the holes in existing extracellular scaffolds were not cell friendly. The cells flattened out and stuck to the sides of the scaffolds and, as such, did not function physiologically as they would in the body. She set out to make a nanoporous material using complex electrospinning techniques and created a synthetic extracellular matrix in which cells grow spontaneously.
The challenge now, notes Green, is to make something that is usable for the medical profession. He expects this could take the shape of a mesh or three-dimensional structure. When a prototype has been constructed, BioCeramic Therapeutics will decide the indication for preclinical work according to the suitability of cell types. Work with the projects, known as BCT 101 and BCT 102, is anticipated to be in vitro by the end of the year and in vivo by the end of 2009.
BioCeramic Therapeutics has an exclusive license to the core patent covering the technologies, which is currently in prosecution.
Competitors to BioCeramic Therapeutics are largely those working in the bone fillers market. The US Nasdaq-listed companies, Orthovita Inc. and BioMimetic Therapeutics Inc., ApaTech Ltd. of the UK, and Bone Support AB, Sweden, are the obvious comparators.
From inception in June 2006 to March 2007, BioCeramic Therapeutics raised just over £1 million from three main investors, which included Imperial Innovations and Comvest Ltd., which specializes in early-stage technology investments. Green believes this was possible because the business model offered "high upside [the generation-two technology] and limited downside [generation one] and in vitro data was already in."
The cash should last into 2009, which means a fund-raising is likely toward the end of 2008. Green says that the money may come from the venture capital community, but a strategic investor is also a possibility. "We are looking for money and looking to build a business. If someone comes along with money and expertise, then that is obviously worth something to us."
Green is passionate about the potential of BioCeramic Therapeutics. He believes that the balance of risk and reward within the company is ideal for growth. "Many medical device companies are one-product companies with relatively limited upside. On the other hand, drug discovery or platform technology companies have huge upside, in principle, but huge costs and risks in order to get there. What BioCeramic Therapeutics combines, I believe, is the best of both worlds."—Lucy Clarke