The tissue engineering market has reached a point of growth inflexion, enforced by a downturn in biotechnology small-cap investment, and rationalization of tissue engineering programs by large cap medical devices and pharmacological organizations. This is strongly demonstrated by the wound management tissue-engineering field. Some companies like Novartis have recognized that existing product formats and cost structures are inappropriate for the wound management customers. As a result, the partnership between Novartis and Organogenesis dissolved at a point where sales seemed to be growing rapidly. Smith & Nephew took longer to receive approval for the Dermagraft product and limited their losses by divesting.

Globally, the market for tissue engineered skin repair and replacement is a $679 million market, with the majority of the market concentrated in the U.S. and Europe, but annual sales growth in Asia/Pacific and in RoW is in excess of 20% and 15%, respectively.

Tissue engineered skin, integumentary and plastic surgery products are detailed in MedMarket Diligence Report #S247, "Worldwide Wound Management" and Report #S520, "Tissue Engineering, Cell Therapy and Transplantation".

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The largest segment in the overall market for regenerative medicine technologies and products comprises orthopedic applications. Other key sectors are cardiac and vascular disease, neurological diseases, diabetes, inflammatory diseases and dental decay and injury.

Factors that are expected to influence this market and its explosive growth include political forces, government funding, clinical trial results, fluctuating industry investment and an increasing awareness among both physicians and the general public of the accessibility of cell therapies for medical applications. The reversal of the U.S. government's ban on federal funding for embryonic stem cell research has given researchers sponsored with federal funding increased access to additional lines of embryonic stem cells. This is expected to result in an increase in the number of research projects being conducted and thus possibly hasten the commercialization of certain products.

Another factor that has influenced the advancement of regenerative technologies is found in China, where the Chinese government has encouraged and sponsored cutting-edge (and some have complained ethically questionable) research. While China’s Ministry of Health has since (in May 2009) established a policy requiring proof of safety and efficacy studies for all gene and stem cell therapies, the fact remains that this research in China has spurred the advancement of (or at least awareness of) newer applications and capabilities of gene and stem cell therapy in medicine.

Meanwhile, tighter regulatory enviroin other areas of Asia (particularly Japan) will serve to temper the overall growth of commercialized tissue and cell therapy–based products in that region. Nonetheless, the growth rate in the Asia/Pacific region is expected to be a healthy 20%.

Meanwhile, growth rates in Europe and other areas outside the United States and Asia/Pacific (rest of world or ROW) are expected to be roughly to growth of the market in Asia. This reflects the fact that European and developing market regulatory requirements allow products to be commercialized more rapidly in those regions. While the rate of growth in the United States for this time period is expected to be slower, this is only due to its larger size and its position ahead of other markets on the classic market growth curve.  Nonetheless, some in Europe worry that research in the United States will accelerate at a more rapid pace now that U.S. researchers have access to additional lines of stem cells. The fear is that this will allow development in regenerative medicine technologies to threaten an eclipse of the gains made in Europe in the past several years.

See Report #S520.

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Currently, OSI Pharmaceuticals has a commanding lead in this area, with its Tarceva being used for pancreatic and non-small cell lung carcinoma.  Overall, the market is controlled by a limited number of players, but many others are in development.

Source: MedMarket Diligence, LLC; Report #S520.

The MedMarket Diligence report #S520, "Worldwide Tissue Engineering, Cell Therapy and Transplantation Market, 2009-2018", covers the developments, products, technologies, markets and companies active in the area of cell therapies and tissue engineering for cancer.  Cancer types covered are the full range encompassing urology, neurology, Ob/Gyn, orthopedic/bone, gastrointestinal/gastroenterology, head & neck, hemotopoietic, and respiratory.

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Below is a sample of surgical sealants, glues and wound closure applications by clinical area:

Surgical Field	Applications
CNS surgery:	1. Adhesive agent in CNS tissue surgery. CNS tissue cannot be sutured. Fibrin glue is almost equivalent to microsurgical suture. Fibrin glue works as a sealant but not a nerve barrier.
	2. Repair of dural defects.
	3. Nonsurgical treatment for postoperative CSF leaks by percutaneous CT guided placement of fibrin glue
Eye surgery:	1. Conjunctival closure in strabismus.
	2. Wound closure in glaucoma.
	3. Lower blepharoplasties (for lower eyelids).
	4. Attachment of extraocular muscles.
	5. Cataract surgery using fibrin glue in radial suture to correct astigmatism.
ENT surgery	1. Myringoplasty in large persistent tympanic membrane perforation.
	2. Repair of laryngotracheal separation with cricoidectomy.
	3. Narrowing of nasal fossa in atrophic rhinitis.
	4. Routine otologic and neuro-otologic surgery.
	5. Vocal fold lateralization in vocal cord defect.
	6. Tympanoplasty.
Oral and dental surgery:	1. Local hemostatic measures in patients with bleeding disorders and patients on anticoagulants.
	2. Sealing of oro-antral fistula.
	3. Correction of periodontal bony defect.
	4. Tissue adhesive with bone chips to prevent bone defect.
Head and neck:	1. Parotidectomy closure.
	2. Axillary dissection in carcinoma of the breast. Reduces adhesion, bleeding and serous drainage with earlier drain.
	3. Prevention of mastectomy seroma.
	4. Treatment of chylous leakage after neck dissection, which is found in (5%) of neck resections.
	5. Axillary lymph node dissection.
Cardiovascular thoracic surgery:	1. Reduced postoperative bleeding and intrapericardial adhesion.
	2. In cardiothoracic surgery using fibrin glue significantly reduced postoperative bleeding.
	3. Repair of left ventricular free wall rupture.
	4. Aortic valve repair.
Chest surgery:	1. Sealing of prolonged air leak after thoracotomy in lung cancer.
	2. Bronchopleural fistula.
	3. Percutaneous lung biopsy.
	4. Large emphysematous bullae using thoracoscopic technique.
	5. Management of postoperative chylothorax in premature babies.
	6. Persistent pneumothorax in premature infants.
Vascular surgery:	1. Microvascular anastomosis: Suture may induce vascular narrowing, foreign body reaction, intravascular thrombosis but are less common in those with fibrin glue application.
	2. Arterial bypass surgery.
	3. Aortic aneurysm repair.
Gastrointestinal surgery:	1. Gastrointestinal sutureless anastomosis-stent.
	2. Esophagus perforation.
	3. Esophago-jejunal anastomosis.
	4. Recurrent tracheo-esophageal fistula.
	5. Upper gastrointestinal tract fistula: Endoscopic obliteration
	6. Cholecysto-jejunostomy (sutureless) using absorbable intraluminal stent.
	7. Repair pancreatic fistula in pancreatic transplantation and pancreatectomy.
	8. Peptic ulcer bleeding.
	9. Seal peritoneal dialysis catheter leakage.
	10. Recto-vaginal and ano-rectal fistula
	11. Improved healing of irradiated bowel anastomosis
Liver surgery:	1. Liver resection in benign and malignant diseases.
	2. Liver transplantation.
Uro/Gynecological system:	1. Colpofixation in stress urinary incontinent.
	2. Intractable transplant-ureteral fistula.
	3. Transvaginal colpo-urethropexy.
	4. Vaso-vasostomy (fibrin glue replaces two-layer suture technique).
	5. Laparoscopic ureteral re-anastomosis.
	6. Partial nephrectomy.
	7. Laparoscopic closure of ureterotomy in porcine model.
Gynecological surgery:	1. Recto-vaginal and ano-rectal fistula.
	2. Anastomosis of the fallopian tube in animals.
Bone & orthopedic surgery:	1. Joint replacement.
	2. Brachial plexus injury repair.
	3. Fracture and other surgery.
	4. Bone graft.
	5. Multiple surgical joint correction in hemophilia.
Plastic surgery:	1. Face lift procedure. Fibrin glue reduces major hematomas and ecchymoses.
	2. Musculo facial plastic surgery, dorsal hand burns, infected skin graft.
	3. Decrease wound contraction in skin graft.
	4. Hemostatic effect on graft of donor site.
	5. Used as skin graft of contaminated wounds in areas difficult to immobilize, (i.e., perineum, gluteal folds, axilla).

Source: MedMarket Diligence, LLC; Report #S520.

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There are countless disorders, diseases, trauma and other conditions of the human body that can be addressed, in principle, by cellular and tissue-based solutions.  These may be due to damage to cells and tissues, such as in burn wounds, skin ulcers, bone fractures and defects and similar conditions in which cell/tissue structure (e.g., skin, bone) is damaged or diseased.  These may also be diseases in which more complex cellular function is at the root, like the insulin-producing islet cells of the pancreas are damaged or destroyed as in diabetes.  And these may also be diseases in which specifically-induced cell and tissue growth may simply “bypass” the disease’s effects, such as in the stimulated growth of new blood vessels (“angiogenesis”) to literally bypass occluded arteries in ischemic heart disease:

The use of growth factors for angiogenesis has been under evaluation and development for some time.  However, in the April 2010 issue of “Journal of Clinical Investigation”, researchers at Yale School of Medicine report on a new method to simply influence a naturally occurring signaling pathway that otherwise inhibits the growth of new blood vessels:

See New Method To Grow Arteries Could Lead To ‘Biological Bypass’ For Heart Disease:

"Successfully growing new arteries could provide a biological option for patients facing bypass surgery," said lead author of the study Michael Simons, M.D., chief of the Section of Cardiology at Yale School of Medicine.

In the past, researchers used growth factors – proteins that stimulate the growth of cells – to grow new arteries, but this method was unsuccessful. Simons and his team studied mice and zebrafish to see if they could simulate arterial formation by switching on and off two signaling pathways – ERK1/2 and P13K.

"We found that there is a cross-talk between the two signaling pathways. One half of the signaling pathway inhibits the other. When we inhibit this mechanism, we are able to grow arteries," said Simons. "Instead of using growth factors, we stopped the inhibitor mechanism by using a drug that targets a particular enzyme called P13-kinase inhibitor."

"Because we’ve located this inhibitory pathway, it opens the possibility of developing a new class of medication to grow new arteries," Simons added. "The next step is to test this finding in a human clinical trial."

Cell therapy and tissue engineering is a broad category of disciplines focused on solving conditions with the involvement, or stimulated growth of, cells and tissues.  See Report #S520 from MedMarket Diligence, LLC.

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Researchers have come to realize that cells cannot simply be laid out in a designed pattern and expected to grow into functional tissue. This is because the cells need specific structural, mechanical and chemical cues to guide cell morphology, migration and proliferation, to regulate cell differentiation, and to modulate cellular processes.

Research and development in this field is expensive; the burn rate is frequently $25 million–$40 million per year, with years of research and testing required before market launch, if indeed that is ever achieved. More than one company has had to declare bankruptcy and either close the doors for good, or reorganize and attempt to find additional funding (Advanced Tissue Sciences, Algenix, Artecel, Cell Based Delivery, to name a few), or sell its assets to another company before making its big breakthrough.

Once a technological breakthrough has been achieved, the company then faces the costs and uncertainties associated with regulatory hurdles, primarily clinical testing. If and when the clinical trials proceed with positive results and market launch appears possible, then the company needs to hire and train a sales force, or must make the strategic decision to give away part of the potential winnings by forming an alliance with a medical device or pharmaceutical company that has the sales network already in place. Also, before launch, the company must prepare to gear up its manufacturing capabilities, again meeting stringent good manufacturing requirements as required in the country of manufacture. Other tasks yet to be completed include acquisition of resources, acquisition of regulatory marketing approval.

From "Tissue Engineering, Cell Therapy and Transplantation, 2009-2018", February 2010; Report #S520.

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Of course January's amount was way above average, but February's was indeed below average, creating a pretty big gap between the January investment of $514 million and the scant $160 million in February VC medtech investment.

The difference, I believe, ensues from the pent-up demand for funding that was unsatisfied in the Q4 of 2009 and unleashed in new year vigor.  February had no chance to continue such a blistering pace. 

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The skin is our protection from the environment. Far from being just a physical barrier, the skin is a complex organ, protecting our bodies from chemical, biological and physical insult, keeping organs and tissues in their place, and regulating various secretions including sweat (to control temperature), and pheromones (to act as sexual attractants). It is constantly renewed and maintained. Injuries to the skin cause the potential for infection and significant disruption to the healthy functioning of the tissues beneath. Healing of the skin has been an essential pre-requisite for evolutionary and individual survival, and complex biochemical systems have evolved for repair of the skin.

Acute Wounds
Surgical wounds account for the vast majority of skin injuries. There are more than 110 million surgical incisions every year, which require some wound management treatment. In approximately 80% of these cases, some form of closure product is used, such as sutures, staples, and tapes. Many require hemostasis (blood clotting) promoters, and of course the use of fabric bandages and surgical dressings is almost universal.

Traumatic wounds occur at a rate of about 1.6 million cases every year. Lacerations are a specific type of trauma wound that are generally minor in nature and require only cleansing and dressing for a shorter period. Lacerations occur frequently (approximately 20 million cases a year), as a result of cuts and grazes. They can usually be treated in the doctor’s surgery, outpatient medical center, or hospital accident and emergency department.

Burns
Burn wounds can be divided into minor burns, medically treated, and hospitalized cases. Outpatient burn wounds are often treated at home, at the physician’s office, or at outpatient clinics. As a result, a large number of these wounds never enter the formal health care system. We estimate that approximately 3.4 million patients in this category do seek outpatient care and receive some level of medical attention. These burns are mostly treated using hydrogels and advanced wound care products or, alternately, with consumer-based products for wound healing. 

Medically treated burn wounds get more specialist levels of care to remove heat from the tissue, maintain hydration, and prevent infection. Advanced wound care products are used on these wounds. There are approximately 6.5 million burns like this treated medically every year.

Hospitalized burn wounds are more rare and require more advanced and expensive care. These victims require significant care, nutrition, debridement, tissue grafting and often tissue engineering where available. They also require significant nursing care and rehabilitation to mobilize new tissue, and physiotherapy to address changes in physiology. 

Chronic Wounds
Chronic wounds generally take longer to heal, and care required is enormously variable, as is the healing time. There is an incidence of approximately 8.5 million pressure ulcers in the world that require treatment every year. Optimally, these wounds receive advanced wound management products and appropriate care to address the underlying defect that has caused the chronic wound. Pressure ulcers are caused by compression of the skin and underlying tissues, as when a patient is bedridden and the buttocks are pressed onto the mattress; a number of advanced devices exist to reduce pressure for patients. Other skin ulcers are caused by poor circulation, even without the added complication of pressure. There are approximately 12.5 million venous ulcers, and approximately 13.5 million diabetic ulcers in the world requiring treatment.

Chronic wounds are growing in incidence due to the growing numbers of elderly individuals in the population, and the caseload is also increasing due to improved diagnosis and education. At present these factors are contributing to growth of this pool of patients faster than new technologies are reducing the incidence of wounds by healing them.

Wound management techniques are also used for a number of other conditions including amputations, carcinomas, melanomas, and other complicated skin cancers, which are all on the increase.

Products Used in Advanced Wound Management
Dressings can be divided into categories using a number of different classification systems. In this report we focus our product, marketing, and technology review on the category known as Advanced Wound Management. This includes film dressings, hydrocolloids, foam dressings, alginate dressings, hydrogels, non-adherent dressings, antimicrobial dressings, cleansing and debridement products, tissue engineered products, pharmacological products, (including pain control, antibiotics, growth factors, non-growth factor modulators, gene therapy, and scarring modulators), physical treatments (like pressure devices, hydrotherapy, electrical stimulation, electromagnetic stimulation, ultraviolet therapy, hyperbaric oxygen therapy, mechanically assisted wound closure devices, ultrasound, laser and information systems. Some of these product categories are well established; others are in development.

Film Dressings
Film dressings are a vital segment of the advanced wound management market. The potential for film dressings in moist wound healing is a concept that is now over 20 years old. Due to the age of many of the strong brands in this segment, key patents on technologies and the delivery/application systems are expiring. This will erode premium prices, which have been maintained by creating new and differentiating application systems and the strong branding that is associated with them. Companies with strong know-how coupled with highly integrated low-cost manufacturing, and strong brand awareness will retain share in the marketplace.
Overall, despite increased competition and price pressure, this market segment will continue to demonstrate positive growth resulting from continued adoption of moist wound healing principles and switching from general non-occlusive dressings to advanced products such as films. The market for transparent film dressings is mature, and although individual products may provide a number of separate features, such as different moisture vapor transmission rates (MVTRs), they are purchased as commodities by buying groups. Given acceptable delivery systems, films compete on price. 

Hydrocolloid Dressings
The market for hydrocolloids grew rapidly in the 1980s and 1990s due to the products’ convenience and the fact that they can be left on some wounds for up to five days, together with widespread experience in their use, significant clinical support, and intensive marketing, that have helped grow sales volume over the years. Clinician customers developed a high awareness of these hydrocolloid brands and effectively substituted them for traditional fabric dressings once they had adopted the rationale for advanced wound care using moist wound healing. Major players in this segment of the market encouraged the use of hydrocolloids for all moist wound healing applications.

Hydrocolloids are used extensively in long-term care sites where wear time and ease of use are determining factors in dressing selection and in hospitals where they are popular with opinion leaders. However, hydrocolloids are now starting to lose ground in the face of competition from newer types of dressings with superior benefits. Sales of hydrocolloids are projected to grow modestly through 2017. ConvaTec, Coloplast, and other strong players will find it increasingly difficult to defend these brands from advancing generic hydrocolloid equivalents produced by lower cost manufacturers with generic cost bases. In addition, there is a growing customer recognition that hydrocolloids have been superseded by other technologies (for example, foam dressings) for some wounds.

Foam Dressings
The ability to outperform hydrocolloids in highly exuding wounds, lack of dressing debris, and moderate cost have made foam dressings one of the fastest growing segments in the advanced wound care market. Foams are expected to maintain an average growth rate in excess of 10%  into the immediate future as these products take share from hydrocolloids due to their superior handling characteristics, and as they erode traditional gauze dressing usage. 

Alginate Dressings
Alginate dressings are popular in the home care and extended care markets where high absorption capacity is used to reduce the number and expense of skilled visits. In deeper wounds, alginates conform to the wound bed and contain exudates better than foam dressings. As with other advanced wound dressings, the alginate market is experiencing pricing pressure due to the continued cost consciousness of many individual country’s health care systems, and the generic nature of these materials and lack of proprietary intellectual property. Use of alginate dressings is especially common on moderate-to-highly exuding wounds. Alginates were quickly categorized as devices and reimbursed in the USA, UK, France and Germany, leading to strong growth in these countries. The relatively strong support for these products by expert wound care clinicians and the need for management of highly exudative wounds led to high sales growth in the mid 1990s. The alginate dressings market segment will grow at around in excess of 10% annually from 2008 to 2017; in 2008.

Hydrogels
Hydrogels are often promoted by referring to their aesthetic cooling effects, which help to reduce wound pain. Hydrogels are now perceived by clinicians as effective in encouraging autolytic debridement, and encouraging the healing of dry or minimally exuding wounds. Amorphous hydrogels and gauze-stabilized formats provide a real advantage in wound packing, and these products have been readily adopted by clinicians. In addition, hydrogels have good potential to serve as delivery systems for active agents. Competitors are actively introducing new hydrogel products to the market, and targeting alternate and home care markets. Thus, hydrogel sales are projected to grow only modestly through 2017.

Approximately 50% of amorphous hydrogel products are used by clinicians to re-hydrate black necrosis or yellow slough for purposes of debridement. The other 50% of amorphous hydrogels are sold for use as a general hydration material for controlling moisture to aid moist wound healing.

Non-Adherent Dressings
Non-adherents are a vital part of the advanced wound management market. Products are used to permit less frequent changes of dressings and to allow the use of dressings that manage higher quantities of exudates but reduce the potential for these dressings to stick to the wound. They are also used in combination with traditional dressings as an alternative to more expensive advanced wound dressings. These dressings are also used as the primary contact layer for compression bandaging systems (although we have excluded sales due to this usage from our market estimates). Thus, non-adherent sales are projected to continue to grow anemically through 2017.

Anti-Microbial Dressings
Anti-microbial dressings are used to manage the effects of microbial colonization and growth. Bacterial infection of wounds is a significant complication of wound repair. There is a growing concern regarding the use of antibiotic products in the wound care environment, and there are few “non-resistant-microbe-forming” antibiotic technologies on the horizon that offer potential to be launched within the next five years. In contrast to this, antimicrobial technologies are being pursued by all wound management companies, to enhance existing brands, and to address the recognized need in this area. Topical antiseptics are one option to treat patients with infected wounds; they act rapidly and locally to destroy microbes. Products fall into a number of categories, which tend to overlap with other categories of wound care products due to the product base technology used for the dressing category that inspired them. For example Tulle Gras delivery systems have been used for some antibacterial products such as Inadine, Bactigras, and generic antibiotic impregnated products. Sales are projected to continue to grow at only a nominal rate through 2017.

Wound Cleansers and Debriding Agents
The wound cleanser and debridement market is expected to grow to an estimated sales value of $375 million in 2008 to more than $695 million in 2017. The enzymatic debridement subsegment of this market is driven by the increase in the elderly population with the corresponding increase in nursing home populations and in-home health care environments where chronic wounds are prevalent. The increasing prevalence of diabetic ulcers contributes to the market potential for these agents.

Skin Replacements and Substitutes
Skin replacements and substitutes compete in the severe burn market, venous leg ulcers market, and the diabetic foot ulcer markets where their high cost is offset by their ability to save lives and/or save limbs from amputation. These products have taken some time to demonstrate clinical effectiveness and to be approved for use to heal wounds faster than alternative treatments. In addition, these products are currently significantly more expensive than alternative therapies, and publicly funded health care schemes around the world have found it difficult to accept these costs despite strong cost-effectiveness claims. It is highly likely that these products will take some time to be widely adopted. The move towards cost- effectiveness procurement practice is likely to increase uptake of these products as purchasers advance from decisions based on unit product cost towards outcomes assessments and data. In addition, manufacturers are developing alternative manufacturing and lower cost product designs that should enhance the cost effectiveness of these products over the next few years.

Pharmacological Products
In the field of wound management there are a large number of companies commercializing technologies in the pharmacological field. These technologies include recombinant growth factors and growth factor mixtures, gene therapy, chemical cell stimulants, natural plant extracts and other pharmaceuticals including analgesics, antibiotics, scar reduction products etc. Advanced wound care practices and dressings have focused on removal of the underlying cause of the wound, altering the physical environment, and provision of a moist wound healing environment. These efforts have greatly improved wound care by facilitating wound repair by supporting the body’s own repair and regenerative processes. Recent interest and efforts have been directed to evolving products and procedures designed to actively manipulate the wound healing process. In addition, antibiotics and analgesics have direct and beneficial application in the treatment of wounds in specific cases.

Physical Therapies
Physical modalities have been used in the attempt to encourage wound healing for centuries. Passive compression is a popular approach for the treatment of venous stasis ulcers and many of the current passive compression products have their roots in traditional practices (e.g., paste bandages). Passive compression addresses the underlying etiology of chronic venous insufficiency.

Alternatively there is a market for devices designed to remove pressure from wounds that have been caused by extended pressure on the skin surface, and this market segment has shown astronomical growth within the past 3-4 years, driven by the demonstrated ability of application of negative (i.e., sub-atmospheric) pressure to speed up and improve the healing of chronic wounds.

There are also a great number of devices that are designed to immobilize limbs to avoid weight-bearing behavior, and sophisticated footwear and devices for diagnosing neuropathy. In addition, devices exist to manipulate pressure around limbs to maintain and improve venous blood flow. There are devices designed to accelerate healing through the use of physical treatments including ultrasound, electrical, magnetic, hyperbaric, and pressure relief.

Taken together, these physicial treatment modalities commanded sales of more than $1.4 billion 

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Below are select technologies under development by companies in cell therapy and tissue engineering. While these are not approved, many are well along in the development/approval process, plus many of the companies developing them already have products on the market.

Orthopedic cell/tissue select technologies in development:

• 3-D cell growth matrix
• Adult-derived stem cell therapies identified to improve the outcomes of cardiac, orthopedic and vascular surgeries
• Anterior cruciate ligament repair
• Autologous cartilage regeneration system
• Autologous disc-derived chondrocyte transplantation for herniated discs
• Bioregeneration matrix
• Bone and tissue cellular matrix (dental, ortho filler)
• Bone graft augmentation
• Bone repair cells for bone regeneration
• Cartilage regeneration, tissue reinforcement and repair
• Cellular implants for the regeneration of damaged or sick orthopedic tissues
• Developing stem cell therapies for bone and joint disease
• Engineered tissue graft for cartilage
• Growth factor for osteoarthritis in knee
• Human cartilage grown from adult stem cells
• Identified potential applications in biomaterial bone grafts
• Injectable for degenerative disc disease
• Investigating marrow and other system for orthopedic applications including spinal fusion
• Material for anterior cruciate ligament repair, scaffolds for rotator cuff tendon repair
• Orthopedic applications (bone fractures, degenerative joint cartilage, damaged intervertebral discs)
• Orthopedic regenerative medicine biomaterials
• Orthopedic scaffolds
• Osteoarthritis pain relief
• Personalized orthopedic stem cell therapy
• Regeneration of myoblasts; stem cells to replace cartilage, bone
• Regenerative medicine (glial cells, cardiomyocytes, islets, chondrocytes, osteoblasts, hepatocytes)
• Regenerative stem cell transplantation
• Scaffold for human tissue regeneration in the lab
• Scaffold for spinal bone regeneration
• Scaffold-free living cartilage implant for knee applications
• Testing a genetically engineered human protein in patients with moderate to severe low back pain
• Tissue regeneration for reconstructive, soft and hard tissue

Skin / Integumentary cell/tissue select technologies in development:

• Allogeneic adult stem cells, protein therapeutics, gene silencing for wound ulcers and other applications
• Amino acid peptide for diabetic foot ulcer healing
• Artificial epidermis
• Biomaterial for wound healing and tissue regeneration
• Cell therapy for scar reduction
• Cellular implants for the regeneration of damaged skin (aesthetics)
• Genetically engineered biomaterials for wounds and other applications
• Lyphoderm human keratinocytes for chronic wounds
• Osteoarthritis pain relief
• Regenerative stem cell transplantation
• Stem cells to replace skin cells (substitute skin)
• Therapeutic for wound closure
• Tissue reinforcement and repair

Source: Report #S520, MedMarket Diligence, LLC

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