Bonesupport

Bonesupport is a Swedish medical technology and biotechnology company focused on products that support bone healing and the management of bone defects. The company was founded in Lund in 1999 by Lars Lidgren, a professor of orthopedic surgery and an academic leader at Lund University Hospital. Its activities developed within the research and medical-technology environment of Lund, including the Ideon Science Park, and were connected to the wider network of orthopedic research and clinical centers associated with the ISOC group. The company's principal technology platform is Cerament, a synthetic, injectable and osteoconductive biomaterial used as a bone substitute. Cerament is designed to fill bone voids and gaps created by trauma, orthopedic surgery or benign tumors, and to support the repair of fractures. Unlike a permanent implant, the material is intended to remodel over time into healthy bone; the reference material describes the remodeling process as generally taking approximately six to twelve months. Its applications include fragility fractures associated with osteoporosis, augmentation of fracture fixation and the treatment of bone defects in orthopedic procedures. Some Cerament formulations can be combined with antibiotics. Cerament G, for example, has been developed for use in situations involving bone infection and osteomyelitis. Antibiotic-loaded versions have regulatory distinctions between markets and formulations: the reference material notes that Cerament containing gentamicin was not FDA approved, while Cerament G had European approval dating back to 2013. The company has also pursued United States regulatory development for Cerament G, including FDA breakthrough-device designations in 2020 and 2021 and the Fortify IDE clinical study. Bonesupport's regulatory and commercial history includes several important milestones. Cerament bone void filler received U.S. Food and Drug Administration approval for sale in the United States in 2005, while Cerament Spine Support received CE marking in 2008 and the bone void filler received CE marking in 2009. In 2012, the company entered an agreement with Biomet (later associated with Zimmer Biomet) granting exclusive distribution rights for the Cerament bone void filler range in the United States and Canada. Bonesupport terminated that arrangement in 2018 and resumed U.S. distribution through independent distributors. The company received more than SEK 500 million in venture capital from investors including HealthCap, the Lundbeck Foundation and Industrifonden, making it one of the larger Swedish medical-technology ventures described in the reference material. Bonesupport applied in June 2017 to list its shares on Nasdaq Stockholm's main market, and trading began on 21 June 2017. The company remains focused on orthopedic and bone-regeneration applications, with Cerament and related formulations as its core product family.

Bonesupport emerged from the orthopedic research environment in Lund, Sweden. It was established in 1999 by Lars Lidgren, a professor of orthopedic surgery and academic head of department at Lund University Hospital. The company's early identity was shaped by the translation of orthopedic and biomaterials research into products intended for use in bone repair. Its base at Ideon Science Park placed it within one of Sweden's established university-linked technology and life-sciences clusters. The company's core development has centered on Cerament, a synthetic injectable biomaterial designed to act as an osteoconductive bone substitute. The material is used where a surgeon needs to fill a bone void or gap caused by trauma, orthopedic surgery or a benign tumor. It has also been positioned for fracture augmentation and for fragility fractures associated with osteoporosis. A key feature of the platform is that it is intended to remodel progressively into healthy bone rather than remain as a permanent structural material. The reference material places the typical remodeling period at approximately six to twelve months. Bonesupport expanded the platform into products addressing more specialized clinical requirements. Cerament Spine Support received a CE mark in 2008, and Cerament bone void filler received CE marking in 2009. The bone void filler had earlier received FDA approval for U.S. sale in 2005. The company also developed antibiotic-loaded formulations for cases in which bone healing occurs in the presence or context of infection, including osteomyelitis. Cerament G received European approval in 2013 according to the reference material. Regulatory status differs by formulation and territory, and the reference specifically notes that a Cerament formulation containing gentamicin was not FDA approved. Commercial expansion in North America included a September 2012 distribution agreement with Biomet. The arrangement granted exclusive rights for the Cerament bone void filler range in the United States and Canada and was intended to increase adoption through an established medical-device distribution channel. Following Biomet's integration into Zimmer Biomet, Bonesupport continued the arrangement until May 2018. It then ended the agreement and took back U.S. distribution, using independent distributors instead. This change represented a shift toward greater control over the company's commercial operations in the U.S. market. Financing was an important part of the company's development. Bonesupport received more than SEK 500 million in venture capital from investors including HealthCap, the Lundbeck Foundation and Industrifonden. The financing made it one of the larger Swedish medical-technology ventures described in the available reference material and supported product development, clinical work and market expansion. Bonesupport became a listed company in 2017. On 11 June, its board applied for admission of the company's shares to Nasdaq Stockholm's main market. Nasdaq Stockholm approved the application subject to customary conditions, and the first day of trading was 21 June 2017. The listing marked a transition from a venture-funded private medical-technology company to a publicly traded business. In the United States, the company continued regulatory development of Cerament G. The product received FDA breakthrough-device designations in both 2020 and 2021. The Fortify IDE study completed follow-up in 2021, with filing to the FDA described in the reference material as planned for the fourth quarter of 2022. These developments reflected Bonesupport's continuing strategy of extending its bone-substitute platform into infection-related and more demanding orthopedic applications. Its documented business remains centered on orthopedic biomaterials, bone void management, fracture treatment and bone regeneration.

• 2021

  Cerament G receives a further FDA designation

  [1]Bonesupporten.wikipedia.org

  Cerament G was again designated a breakthrough device by the FDA, while the Fortify IDE study completed follow-up.

• 2020

  Cerament G receives FDA breakthrough-device designation

  [1]Bonesupporten.wikipedia.org

  Cerament G received a breakthrough-device designation from the FDA.

• 2018

  U.S. distribution returns in-house

  [1]Bonesupporten.wikipedia.org

  Bonesupport ended its distribution agreement with Zimmer Biomet and resumed U.S. distribution through independent distributors.

• 2017

  Bonesupport lists on Nasdaq Stockholm

  [1]Bonesupporten.wikipedia.org

  The company applied for a main-market listing in June, and its shares began trading on Nasdaq Stockholm on 21 June.

• 2013

  Cerament G is approved in Europe

  [1]Bonesupporten.wikipedia.org

  Cerament G was approved in Europe, according to the reference material.

• 2012

  Biomet becomes North American distributor

  [1]Bonesupporten.wikipedia.org

  Bonesupport entered an agreement granting Biomet exclusive distribution rights for the Cerament bone void filler range in the United States and Canada.

• 2009

  Cerament bone void filler receives CE marking

  [1]Bonesupporten.wikipedia.org

  The Cerament bone void filler product received CE marking in Europe.

• 2008

  Cerament Spine Support receives CE marking

  [1]Bonesupporten.wikipedia.org

  Cerament Spine Support received a CE mark for the European market.

• 2005

  Cerament bone void filler receives FDA approval

  [1]Bonesupporten.wikipedia.org

  Cerament bone void filler received approval from the U.S. Food and Drug Administration for sale in the United States.

• 1999

  Bonesupport is founded in Lund

  [1]Bonesupporten.wikipedia.org

  Lars Lidgren founded the Swedish orthopedic medical-technology company in Lund, building on the local university and clinical research environment.

A specialist orthopedic medical-technology company positioned around synthetic, injectable and remodelable bone substitutes that fill bone defects and support bone regeneration, including applications involving fracture repair and bone infection.

• Injectable synthetic bone substitute

  Cerament

  Cerament is Bonesupport's principal synthetic, injectable and osteoconductive biomaterial platform. It is used to fill bone voids and gaps created by trauma, orthopedic surgery or benign tumors, and to augment fracture repair. The material is designed to support bone healing and to remodel into healthy bone over approximately six to twelve months.

• Bone void filler · 2005

  Cerament Bone Void Filler

  Cerament Bone Void Filler is intended for filling bone defects and voids in orthopedic procedures, including defects resulting from trauma or surgery. It received FDA approval for U.S. sale in 2005 and CE marking in 2009. The product was distributed in North America through Biomet and later Zimmer Biomet before Bonesupport resumed U.S. distribution through independent distributors.

• Spinal bone-support biomaterial · 2008

  Cerament Spine Support

  Cerament Spine Support is a Cerament product for spinal orthopedic applications. Its European regulatory history includes a CE mark received in 2008. The product belongs to the company's broader effort to apply injectable bone-substitute technology to specialized orthopedic procedures.

• Antibiotic-loaded bone substitute · 2013

  Cerament G

  Cerament G is an antibiotic-loaded Cerament formulation developed for bone-healing situations involving infection, including osteomyelitis. The reference material states that it has been approved in Europe since 2013. In the United States, it received FDA breakthrough-device designations in 2020 and 2021 and was evaluated through the Fortify IDE study.

• 2020

  Advancing Cerament G through the FDA breakthrough-device pathwayOther

  Background

  Bonesupport was developing Cerament G for bone-healing applications involving infection and seeking further U.S. regulatory progress.

  Action taken

  Cerament G received an FDA breakthrough-device designation in 2020 and a further designation in 2021; the Fortify IDE study completed follow-up in 2021.

  Aftermath

  The reference material stated that the study would be filed with the FDA in the fourth quarter of 2022.

  Source

• 2018

  Taking back U.S. distributionStrategy

  Background

  Bonesupport's North American distribution arrangement had originated with Biomet in 2012 and continued under Zimmer Biomet.

  Action taken

  The company ended the U.S. distribution agreement with Zimmer Biomet and moved to a network of independent distributors.

  Aftermath

  Bonesupport regained direct responsibility for distribution in the U.S. market.

  Source

• 2017

  Pursuing a Nasdaq Stockholm main-market listingOther

  Background

  After years of venture-capital-backed development, Bonesupport pursued access to public equity markets.

  Action taken

  The board applied for admission of the company's shares to Nasdaq Stockholm's main market, and the application was approved subject to customary conditions.

  Aftermath

  The shares began trading on 21 June 2017.

  Source

• 2012

  Appointing Biomet as exclusive North American distributorStrategy

  Background

  Bonesupport sought to accelerate adoption of its Cerament bone void filler in the United States and Canada through a major established medical-device company.

  Action taken

  The company entered a distribution agreement giving Biomet exclusive rights for the Cerament bone void filler range in the two markets.

  Aftermath

  The arrangement continued after Biomet became associated with Zimmer Biomet and ended in 2018.

  Source

• 2020.04.29

  Reported2020.04.29

  BONESUPPORT announces Michael Roth appointment[2]BONESUPPORT宣布任命Michael Rothprnewswire.com

  BONESUPPORT announced a leadership change scheduled for June 1, 2020, when Michael Roth is to start as General Manager and Executive Vice President Commercial Operations North America.

Read more

1. 1Bonesupporten.wikipedia.org
2. 2BONESUPPORT宣布任命Michael Rothprnewswire.com