Integra LifeSciences

Last updated
Integra LifeSciences Holdings Corporation
IART
Company type Public
IndustryMedical technology
Founded1989;35 years ago (1989) [1]
Headquarters Princeton, New Jersey, U.S.
Key people
Jan De Witte (CEO) [2]
Products
Revenue US$1.3 billion (2020) [1]
Number of employees
approx. 3,946 (Dec. 2023)
Website integralife.com

Integra LifeSciences Holdings Corporation is a global medical device manufacturing company headquartered in Princeton, New Jersey. [3] [4] Founded in 1989, the company manufactures products for skin regeneration, neurosurgery, reconstructive and general surgery. [3] Integra artificial skin became the first commercially reproducible skin tissue used to treat severe burns and other skin wounds. [5] [6]

Contents

History

Integra LifeSciences was founded by Richard Caruso in 1989 after Caruso licensed Integra artificial skin technology from Harvard–MIT and acquired Colla-tec, a subsidiary of Marion Laboratories. [3] [7] The company became publicly traded under the NASDAQ ticker name IART. [7]

In 1996, Integra artificial skin was approved by the U.S. Food and Drug Administration. [8] The artificial skin, manufactured and patented as Integra, is now used on patients with extensive burns. [5] In 1999, the FDA approved Integra LifeSciences’ DuraGen, an absorbable implant used in neurosurgical and spinal procedures. [9]

In 2001, NMT, a company acquired by Integra in 2002, [10] received FDA approval for Licox, a brain tissue oxygen and temperature monitor. [11] [12] Licox is used to treat patients in critical care, including those suffering from traumatic brain injuries. [11]

In 2002, the FDA approved the use of Integra Dermal Regeneration Template for reconstructive surgery of burn scars. [13] In 2016, IDRT received premarket approval from the FDA for the treatment of diabetic foot ulcers. [14]

In 2018, Integra LifeSciences was included in Fortune’s list of Fastest Growing Companies. [15]

In 2023, Integra ranked #59 on Medical Design and Outsourcing’s list of largest medical technology companies in the world. [16]

Integra artificial skin

In 1969, John F. Burke, a surgeon and Harvard Medical School professor, and Ioannis V. Yannas, a mechanical engineering professor of fibers and polymers at MIT, began working on a new form of artificial skin. [5] They created the first commercially reproducible artificial skin, later patented and manufactured as Integra. [5]

Integra is used to treat patients with severe burns. [5] [6] [8] The top layer, made of thin silicone, protects the patient from infection and dehydration, common causes of death after being severely burned. [5] [8] The bottom layer, made of animal tissue, acts as scaffolding where new skin will grow. [5] [17] Compared to traditional skin grafts, the use of Integra reduces pain and scarring. [5] [8] [17] [6]

Integra is also used in plastic surgery, reconstructive surgery, and to treat some forms of cancer and other skin wounds. [6] [18] [19] [20]

Acquisitions

In October 2014, Integra LifeSciences acquired instrumentation lines from Medtronic for $60 million. [21] In January 2014, the company bought Covidien’s Confluent Surgical line of sealants and shields. [22]

In July 2015, Integra LifeSciences acquired TEI Biosciences and TEI Medical and began manufacturing their SurgiMend and PriMatrix product lines. [23] [24] Primatrix, a dermal repair scaffolding product, is used to treat diabetic foot ulcers, burns, and in other procedures. [25] [26]

In January 2017, Integra Lifesciences acquired Derma Sciences for $204 million. [27] Their TCC-EZ Total Contact Cast, used to treat diabetic foot ulcers, reduces pressure and shortens application time compared to a conventional total contact cast. [27] [28] [29]

In October 2017, Integra LifeSciences acquired Johnson & Johnson’s Codman Neurosurgery business for $1.045 billion. [30] The Codman Hakim valve was developed as a new way to treat hydrocephalus. [31] [32]

In January 2021, the company acquired regenerative medicine firm, ACell, for $400M. [33] [34]

Related Research Articles

<span class="mw-page-title-main">Scar</span> Area of fibrous tissue that replaces normal skin after an injury

A scar is an area of fibrous tissue that replaces normal skin after an injury. Scars result from the biological process of wound repair in the skin, as well as in other organs, and tissues of the body. Thus, scarring is a natural part of the healing process. With the exception of very minor lesions, every wound results in some degree of scarring. An exception to this are animals with complete regeneration, which regrow tissue without scar formation.

<span class="mw-page-title-main">Wound healing</span> Series of events that restore integrity to damaged tissue after an injury

Wound healing refers to a living organism's replacement of destroyed or damaged tissue by newly produced tissue.

DePuy Synthes is a franchise of orthopaedic and neurosurgery companies. Acquired by Johnson & Johnson in 1998, its companies form part of the Johnson & Johnson MedTech business segment. DePuy develops and markets products under the Codman, DePuy Mitek, DePuy Orthopaedics and DePuy Spine brands.

<span class="mw-page-title-main">Maggot therapy</span> Wound care by maggot therapy

Maggot therapy is a type of biotherapy involving the introduction of live, disinfected maggots into non-healing skin and soft-tissue wounds of a human or other animal for the purpose of cleaning out the necrotic (dead) tissue within a wound (debridement), and disinfection.

<span class="mw-page-title-main">Venous ulcer</span> Skin sore sustained by a vasculatory disease

Venous ulcer is defined by the American Venous Forum as "a full-thickness defect of skin, most frequently in the ankle region, that fails to heal spontaneously and is sustained by chronic venous disease, based on venous duplex ultrasound testing." Venous ulcers are wounds that are thought to occur due to improper functioning of venous valves, usually of the legs. They are an important cause of chronic wounds, affecting 1% of the population. Venous ulcers develop mostly along the medial distal leg, and can be painful with negative effects on quality of life.

The history of wound care spans from prehistory to modern medicine. Wounds naturally heal by themselves, but hunter-gatherers would have noticed several factors and certain herbal remedies would speed up or assist the process, especially if it was grievous. In ancient history, this was followed by the realisation of the necessity of hygiene and the halting of bleeding, where wound dressing techniques and surgery developed. Eventually the germ theory of disease also assisted in improving wound care.

<span class="mw-page-title-main">Negative-pressure wound therapy</span> Therapeutic technique

Negative-pressure wound therapy (NPWT), also known as a vacuum assisted closure (VAC), is a therapeutic technique using a suction pump, tubing, and a dressing to remove excess exudate and promote healing in acute or chronic wounds and second- and third-degree burns. The therapy involves the controlled application of sub-atmospheric pressure to the local wound environment using a sealed wound dressing connected to a vacuum pump. The use of this technique in wound management started in the 1990s and this technique is often recommended for treatment of a range of wounds including dehisced surgical wounds, closed surgical wounds, open abdominal wounds, open fractures, pressure injuries or pressure ulcers, diabetic foot ulcers, venous insufficiency ulcers, some types of skin grafts, burns, sternal wounds. It may also be considered after a clean surgery in a person who is obese.

Total disc replacement (TDR), or artificial disc replacement (ADR), is a type of arthroplasty in which degenerated intervertebral discs in the vertebral column are replaced with artificial disc implants in the lumbar (lower) or cervical (upper) spine. The procedure is used to treat chronic, severe low back pain and cervical pain resulting from degenerative disc disease. Disc replacement is also an alternative intervention for symptomatic disc herniation with associated arm and hand, or leg symptoms.

ACell is a biotechnology company based in Maryland, United States. The company works in regenerative medicine, in which it owns several extracellular matrix patents. ACell develops, manufactures and markets products for medical and veterinary applications. The company was founded by Alan R. Spievack, a former associate professor at Harvard Medical School and is currently run by Patrick A. McBrayer.

<span class="mw-page-title-main">Artificial skin</span> Material to regenerate or replace skin

Artificial skin is a collagen scaffold that induces regeneration of skin in mammals such as humans. The term was used in the late 1970s and early 1980s to describe a new treatment for massive burns. It was later discovered that treatment of deep skin wounds in adult animals and humans with this scaffold induces regeneration of the dermis. It has been developed commercially under the name Integra and is used in massively burned patients, during plastic surgery of the skin, and in treatment of chronic skin wounds.

Transdermal Continuous Oxygen Therapy is a wound closure technique for chronic and acute wounds which blankets a wound in oxygen on a 24-hour basis until the wound heals. Unlike hyperbaric oxygen treatment for chronic wounds, oxygen treatment used in this therapy is not systemic in nature and treats only the wound area. This treatment differs from topical oxygen treatments, as topical oxygen typically involves sporadic treatments of 1–3 hours several times per week, while TCOT treatment is 24/7 by nature.

Acellular dermis is a type of biomaterial derived from processing human or animal tissues to remove cells and retain portions of the extracellular matrix (ECM). These materials are typically cell-free, distinguishing them from classical allografts and xenografts, can be integrated or incorporated into the body, and have been FDA approved for human use for more than 10 years in a wide range of clinical indications.

Richard E. Caruso was an American entrepreneur, who was the founder and chairman of Integra LifeSciences and other companies. In 2006, Caruso was named the Ernst and Young National Entrepreneur of the Year for the United States.

The dermal equivalent, also known as dermal replacement or neodermis, is an in vitro model of the dermal layer of skin. There is no specific way of forming a dermal equivalent, however the first dermal equivalent was constructed by seeding dermal fibroblasts into a collagen gel. This gel may then be allowed to contract as a model of wound contraction. This collagen gel contraction assay may be used to screen for treatments which promote or inhibit contraction and thus affect the development of a scar. Other cell types may be incorporated into the dermal equivalent to increase the complexity of the model. For example, keratinocytes may be seeded on the surface to create a skin equivalent, or macrophages may be incorporated to model the inflammatory phase of wound healing.

Avita Medical is a clinical and commercial company developing and marketing a range of respiratory and regenerative products. The first regenerative medicine product brought to the market by Avita Medical was ReCell spray-on skin for the treatment of burns. The two latest products are ReNovaCell, for Aesthetics and Plastic applications including skin trauma, and ReGenerCell for the treatment of chronic wounds. The Avita Medical regenerative product range is currently marketed in Europe, the Middle East, Africa (EMEA) and Australia.

<span class="mw-page-title-main">Edwards Lifesciences</span> American biotechnology company

Edwards Lifesciences is an American medical technology company headquartered in Irvine, California, specializing in artificial heart valves and hemodynamic monitoring. It developed the SAPIEN transcatheter aortic heart valve made of cow tissue within a balloon-expandable, cobalt-chromium frame, deployed via catheter. The company has manufacturing facilities at the Irvine headquarters, as well as in Draper, Utah; Costa Rica; the Dominican Republic; Puerto Rico; and Singapore; and is building a new facility due to be completed in 2021 in Limerick, Ireland.

<span class="mw-page-title-main">Diabetic foot ulcer</span> Medical condition

Diabetic foot ulcer is a breakdown of the skin and sometimes deeper tissues of the foot that leads to sore formation. It is thought to occur due to abnormal pressure or mechanical stress chronically applied to the foot, usually with concomitant predisposing conditions such as peripheral sensory neuropathy, peripheral motor neuropathy, autonomic neuropathy or peripheral arterial disease. It is a major complication of diabetes mellitus, and it is a type of diabetic foot disease. Secondary complications to the ulcer, such as infection of the skin or subcutaneous tissue, bone infection, gangrene or sepsis are possible, often leading to amputation.

Total contact casting (TCC) is a specially designed cast designed to take weight off of the foot (off-loading) in patients with diabetic foot ulcers (DFUs). Reducing pressure on the wound by taking weight off the foot has proven to be very effective in DFU treatment. DFUs are a major factor leading to lower leg amputations among the diabetic population in the US with 85% of amputations in diabetics being preceded by a DFU. Furthermore, the five-year post-amputation mortality rate among diabetics is estimated at 45% for those with neuropathic DFUs.

Bioelectromagnetic medicine deals with the phenomenon of resonance signaling and discusses how specific frequencies modulate cellular function to restore or maintain health. Such electromagnetic (EM) signals are then called medical information, which are used in health informatics.

<span class="mw-page-title-main">Ovine forestomach matrix</span> Regenerative medical device platform

Ovine forestomach matrix (OFM) is a layer of decellularized extracellular matrix (ECM) biomaterial isolated from the propria submucosa of the rumen of sheep. OFM is used in tissue engineering and as a tissue scaffold for wound healing and surgical applications

References

  1. 1 2 https://investor.integralife.com/static-files/2b15533d-3c34-4583-991c-86139e821468 [ bare URL PDF ]
  2. ↑ "Integra Lifesciences announces new CEO". 28 October 2021.
  3. 1 2 3 Trenton, Joyce J. Persico | For The Times of (2011-09-30). "Integra upgrades Plainsboro office for skin regeneration market". nj. Retrieved 2021-10-12.
  4. ↑ "Integra LifeSciences Celebrates New Global Headquarters". New Jersey Business Magazine. Retrieved 2021-10-12.
  5. 1 2 3 4 5 6 7 8 Vitello, Paul (2011-11-05). "Dr. John F. Burke, Dies at 89; Created Synthetic Skin". The New York Times. ISSN   0362-4331 . Retrieved 2021-10-08.
  6. 1 2 3 4 "New healing, hope for burn victims | The Seattle Times". archive.seattletimes.com. Retrieved 2021-10-08.
  7. 1 2 Crosby, John C. (2019-06-13). Built to Help Each Other: Mentoring in the Life of Richard Caruso: An Uncommon Man. Radius Book Group. ISBN   978-1-63576-708-7.
  8. 1 2 3 4 Schaffer, Amanda (2006-05-02). "Cadaver Skin Fills the Gap in Burn Cases". The New York Times. ISSN   0362-4331 . Retrieved 2021-10-14.
  9. ↑ "Integra Lifesciences Cleared to Market New Dural Graft Matrix". www.meddeviceonline.com. Retrieved 2021-10-14.
  10. ↑ https://investor.integralife.com/news-releases/news-release-details/integra-lifesciences-acquires-neurosciences-division-nmt-medical [ bare URL ]
  11. 1 2 Stewart, Campbell (December 1, 2008). "The New Licox Combined Brain Tissue Oxygen and Brain Temperature Monitor". Neurosurgery. 63 (6): 1159–1165. doi:10.1227/01.NEU.0000333265.19131.7C. PMID   19057329. S2CID   33380827 – via Oxford Academic.
  12. ↑ Layon, Joseph A.; Gabrielli, Andrea; Friedman, William A. (2013). Textbook of Neurointensive Care. Springer. p. 135. ISBN   978-1-4471-5225-5.
  13. ↑ "FDA approves Integra Omnigraft Dermal Regeneration Matrix to treat diabetic foot ulcers". FDA. 2018-11-03. Retrieved 2021-10-14.
  14. ↑ "Premarket Approval (PMA)". www.accessdata.fda.gov. Retrieved 2021-10-14.
  15. ↑ "Inside Fortune's 2018 Fastest-Growing Companies List". Fortune. Retrieved 2022-03-01.[ permanent dead link ]
  16. ↑ "The 2023 Medtech Big 100: The world's largest medical device companies". Medical Design and Outsourcing. Retrieved 2023-09-03.
  17. 1 2 FDA Consumer 2002-06: Vol 36 Iss 3. Superintendent of Documents. June 2002.
  18. ↑ Thinda, Sumeer; Wright, Harry V.; Mawn, Louise A. (February 2012). "Integra Bilayer Matrix Wound Dressing Closure of Large Periorbital Traumatic Wound". Arch Ophthalmol. 130 (2): 217–219. doi:10.1001/archopthalmol.2011.1178. PMID   22332215 – via JAMA Network.
  19. ↑ Chang, Daniel K.; Louis, Matthew R.; Gimenez, Alejandro; Reece, Edward M. (August 2, 2019). "The Basics of Integra Dermal Regeneration Template and its Expanding Clinical Applications". Seminars in Plastic Surgery. 33 (3): 185–189. doi:10.1055/s-0039-1693401. PMC   6680073 . PMID   31384234.
  20. ↑ Chalmers, R L; Smock, E; Geh, J L C (March 23, 2010). "Experience of Integra(®) in cancer reconstructive surgery". Journal of Plastic, Reconstructive & Aesthetic Surgery. 63 (12): 2081–2090. doi:10.1016/j.bjps.2010.02.025. PMID   20335086 – via National Library of Medicine.
  21. ↑ "Integra LifeSciences closes MicroFrance, Xomed buy from Medtronic". MassDevice. October 27, 2014.
  22. ↑ "Covidien closes $235M divestiture of Confluent to Integra LifeSciences". MassDevice. January 16, 2014. Retrieved 2022-01-19.
  23. ↑ "Integra LifeSciences Completes Acquisition Of TEI Biosciences, TEI Medical". www.meddeviceonline.com. 2015-07-20. Retrieved 2022-02-22.
  24. ↑ "510(k) Premarket Notification". www.accessdata.fda.gov. Retrieved 2022-02-22.
  25. ↑ Karr, Jeffrey (2011). "Retrospective Comparison of Diabetic Foot Ulcer and Venous Stasis Ulcer Healing Outcome Between a Dermal Repair Scaffold (PriMatrix) and a Bilayered Living Cell Therapy (Apligraf)". Advances in Skin & Wound Care. 24 (3): 119–125. doi:10.1097/01.ASW.0000395038.28398.88. PMID   21326023. S2CID   26391378.
  26. ↑ Parcells, Alexis Lanteri; Karcich, Jenika; Granick, Mark S.; Marano, Michael A. (2014-09-24). "The Use of Fetal Bovine Dermal Scaffold (PriMatrix) in the Management of Full-Thickness Hand Burns". ePlasty. 14: e36. ISSN   1937-5719. PMC   4182964 . PMID   25328569.
  27. 1 2 Hodsden, Suzanne (2017-01-13). "Integra LifeSciences Acquirers Derma Sciences for $204M, Expands Regenerative Technology Offerings". www.meddeviceonline.com. Retrieved 2022-02-17.
  28. ↑ Arnold, Jonathan F.; Marmolejo, Valerie (October 2017). "Outcomes Achieved With Use of a Prefabricated Roll-On Total Contact Cast". Foot & Ankle International. 38 (10): 1126–1131. doi:10.1177/1071100717716486. ISSN   1944-7876. PMID   28800712. S2CID   40470722.
  29. ↑ Messenger, Grace; Masoetsa, Richard; Hussain, Imtiaz (2018-06-07). "A Narrative Review of the Benefits and Risks of Total Contact Casts in the Management of Diabetic Foot Ulcers". The Journal of the American College of Clinical Wound Specialists. 9 (1–3): 19–23. doi:10.1016/j.jccw.2018.05.002. ISSN   2213-5103. PMC   6304285 . PMID   30591897.
  30. ↑ Newmarker, Chris (2017-10-02). "Integra LifeSciences completes purchase of J&J's Codman Neurosurgery". MassDevice. Retrieved 2022-02-09.
  31. ↑ Gunderman, Richard; Lopez, Gloria (2019-01-17). "Who was Hakim?" (PDF). Journal of Radiology and Medical Imaging. ISSN   2637-885X – via MEDDOCS Open Access Publisher.
  32. ↑ Sussman, Ph.D, Marvin (2011-05-09). "Dr. Salomon Hakim – a Giant in the Field of Hydrocephalus". Hydrocephalus Association. Retrieved 2022-02-09.
  33. ↑ "Integra LifeSciences to acquire ACell". MassDevice. 2020-12-16. Retrieved 2022-01-12.
  34. ↑ "Integra (IART) Acquires Acell, Focuses on Regenerative Space". Nasdaq. January 21, 2021.
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