Approved Products | HealthCap

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Pharmaceuticals

Abstral

Company: Orexo

Product introduction: Abstral® is a drug that provides fast and effective treatment of breakthrough pain in cancer patients. It is based on Orexo’s sublingual tablet technology and the analgesic fentanyl.

Launched year: 2008

Aeroneb® Pro

Company: Aerogen

Product information: The Aeroneb^® Pro is Aerogen’s flagship nebulizer for aerosol therapy. Aeroneb^® Pro is a proven nebulizer for effectively treating mechanically ventilated patients . The Aeroneb^® Pro is a reusable, multi-patient use nebulizer which is suitable for hospital environments where the appropriate sanitization facilities are available.

This autoclavable nebulizer provides effective dose delivery of physician- prescribed inhalation solutions for infants through adults in both on and off ventilator applications. Therapy can be delivered using an aerosol mask or a mouthpiece in an off ventilator application, see the Instructions for Use manual for more information.

Utilizing Aerogen’s OnQ™ Aerosol Generator, the Aeroneb^® Pro produces a fine particle, low velocity aerosol without environmentally unfriendly propellants, inefficient compressors or costly ultrasonic elements. The Aeroneb^® Pro nebulizer is a vibrating mesh nebulizer in a class of its own.

Launched year: 2002

Arestin

Company: Orapharma Inc

Product introduction: Arestin® (minocycline HCl) is a subgingival sustained-release product containing the antibiotic minocycline hydrochloride incorporated into a bioresorbable polymer for professional subgingival administration into periodontal pockets.

Launched year: 2002

Beleodaq

Company: Onxeo

Product introduction: Beleodaq® (belinostat) is a histone deacetylase inhibitor indicated for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). This indication is approved under accelerated approval based on tumor response rate and duration of response.

Launched year: 2014

Ceplene

Company: Maxim Pharmaceuticals

Product introduction: Ceplene® (histamine dihydrochloride) is an immune-enhancing product which is intended to use in combination with interleukin-2 (IL-2) as a remission maintenance treatment of acute myeloid leukemia.

Launched year: 2010

CERAMENT™|BONE VOID FILLER

Company: Bonesupport AB

Product description: The CERAMENT™|BONE VOID FILLER is ceramic bone void filler intended only for orthopedic applications as a filler for gaps and voids that are not intrinsic to the stability of the bony structure. It provides bone void filler that resorbs and is replaced by bone during the healing process. The product is intended to be injected into bony voids or gaps in the skeletal system, i.e. extremities, spine, and pelvis.

Indication: Bone cysts; bone defects caused by various reasons

CE mark received: 2009

FDA clearance received: 2005

CERAMENT™|GENTAMICIN and supporting systems

Company: Bonesupport AB

Product description: The CERAMENT™|GENTAMICIN is an injectable formulation of synthetic bioceramic bone substitute and the antibiotic drug gentamicin. The biomaterial consists of calcium sulphate and hydroxyapatite combined with liquid Iohexol creates a highly injectable, osteoconductive and bioactive material. It is designed to mimic human cancellous bone by providing short term resorbable support for the fracture or bone void, and longer term osteoconductive support which enhances new bone growth.

Indication: Osteomyelitis

CE mark received: 2013

CERAMENT™|SPINE SUPPORT

Company: Bonesupport AB

Product description: The CERAMENT™|SPINE SUPPORT is an injectable ceramic bone substitute intended to use in the stabilization of vertebral compression fractures in the vertebral body. It is the only fully injectable biological material with C.E. MARK for the treatment of Vertebral Compression Fractures offering clinically demonstrated bone remodelling / healing.

Indication: Spinal compression fracture

CE mark received: 2008

Chartis Pulmonary Assessment System

Company: Pulmonx

Indicator: Emphysema

Product description: The Chartis System is a unique assessment tool that provides precise flow and pressure readings at the lobar or segmental level. This information enables the physician to make assessments regarding the level of collateral ventilation, or inter-lobar airflow in the lungs. Collateral ventilation (CV) can limit the effectiveness of endobronchial lung-volume reduction therapy, and is therefore an important predictor of EBV treatment success.

By directly detecting the presence of CV in the targeted lobes of the lungs, this innovative technology platform empowers physicians to plan data-driven treatment with Zephyr valve therapy.

FDA clearance received: 2009

Crysvita

Company: Ultragenyx

Product introduction: Crysvita (burosumab) is an anti-FGF23 fully human monoclonal antibody for the treatment of X-linked hypophosphatemia (XLH) in children. XLH is a rare, chronic progressive musculoskeletal disorder that affects children and adults.

Launched year: 2018

DOJOLVI

Company: Ultragenyx

Product introduction: Dojolvi™ (UX007/triheptanoin) is the first FDA-approved therapy for the treatment of long-chain fatty acid oxidation disorders, a group of rare, lifelong and life-threatening genetic disorders in which the body is unable to convert long-chain fatty acids into energy.

Launched year: 2020

Edluar

Company: Orexo

Product introduction: Edluar® (zolpidem tartrate) is based on Orexo’s sublingual tablet technology and the active substance zolpidem and offers treatment for short-term insomnia. The Edluar tablet is placed under the tongue where it rapidly dissolves and the active substance is absorbed through the mucous membrane.

Launched year: 2009

Femifect

Company: Lumavita

Product introduction: FemiFect® (pentamycin), a broad-spectrum macrolide antibiotic, is approved for the treatment of vaginitis.

Launched year: 2010

Firazyr

Company: Jerini (Shire)

Product introduction: Firazyr® (icatibant) Injection for the treatment of acute attacks of a rare condition hereditary angioedema (HAE) in people ages 18 years and older.

Launched year: 2009

Innohep

Company: Pharmion

Product introduction: Innohep® (tinzaparin sodium) is a low molecular weight heparin (LMWH) with antithombotic properties indicated for the treatment and prophylaxis of deep vein thrombosis and pulmonary embolism.

Launched year: 2008

MEPSEVII

Company: Ultragenyx

Product introduction: MEPSEVII™ (vestronidase alfa) is an enzyme replacement therapy indicated in pediatric and adult patients for the treatment of Mucopolysaccharidosis VII (MPS VII, Sly syndrome).

Launched year: 2017

Mips Brain Protection System BPS

Company: Mips

Product description: In a helmet with MIPS Brain Protection System the shell and the liner are separated by a low friction layer. When a helmet with MIPS Brain Protection System is subjected to an angled impact, the low friction layer allows the helmet to slide relative to the head. The brain is surrounded by a low-friction cushion of cerebrospinal fluid that protects it by allowing it to slide slightly on impact. MIPS imitates the brain’s way of protecting itself by giving the helmet its own low-friction layer between the outer shell and the liner, which

also slides to absorb much of the energy created by an angled blow to the head.

Navigated Brain Stimulation (NBS) System 4

Company: Nexstim

Product description: The product is a new navigated brain stimulation device for non-invasive direct cortical mapping in clinical neurosurgery and clinical research into applications of navigated repetitive transcranial magnetic stimulation (rTMS). It combines MRI-guided TMS with EMG measurement and incorporates DICOM export to surgical planning systems, surgical navigators and microscopes. The device is fully self-contained and mobile, does not require a dedicated room or fixed installation, and has a floor footprint of less than 0.6 m².

Clinical applications: Pre-operational direct brain functional mapping

CE mark and FDA clearance received

NBT® System

Company: Nexstim

Product description: NBT^® works by using navigated rTMS at a slow frequency in order to help restore the brain´s natural inhibitory balance between its two hemispheres: allowing the injured side of the brain to benefit from subsequent physiotherapy. It is a non-invasive, personalized adjunct therapy to standard physiotherapy.

Clinical applications: Stimulation therapy for stroke rehabilitation

CE mark received: 2012

Opsumit

Company: Actelion

Product introduction: Opsumit® (macitentan) is an orally available endothelin receptor antagonist (ERA) that resulted from a tailored drug discovery process with the target of developing an ERA to address efficacy and safety.

Launched year: 2013

Refludan

Company: Pharmion

Product introduction: Refludan® (Lepirudin) is a recombinant hirudin derived from yeast cells and acts as a highly specific direct inhibitor of thrombin. The product is indicated to treat anticoagulation in patients with heparin-induced thrombocytopenia and associated thromboembolic disease.

Launched year: 2008

Restylane

Company: Q-Med

Product description: Restylane is the trade name for a range of injectable fillers with a specific formulation of non-animal sourced hyaluronic acid (HA). Restylane was the first stabilized hyaluronic acid filler on the market and reportedly has been used in over 11 million treatments worldwide. In the United States, Restylane was the first hyaluronic acid filler to be approved by the FDA for cosmetic injection into sub dermal facial tissues.

FDA Approval: 2003

ReValvingTM system

Company: CoreValve (Medtronic)

Product description: Corevalve has developed the ReValving^TM system for replacing an aortic heart valve by a peripheral, intravascular, percutaneous approach. The device is based on a catheter delivery system containing a self-expanding frame hosting a tissue valve. The product has revolutionized the medical practice moving from open surgery to a percutanous process where the valve together with its frame will be placed in the heart via a peripheral vessel.

Indication: severe aortic stenosis patients who are too ill or frail to have open-heart surgery for aortic valves replacement

CE mark received: 2007

RhinoChill IntraNasal Cooling System

Company: BeneChill

Product description: RhinoChill® IntraNasal Cooling System is a hypothermal device that simultaneously implement conductive cooling, evaporative cooling and convective cooling system to facilitate heat transfer. The product uses a transnasal evaporative catheter to deliver a mist of liquid perfluorocarbon into the nasal cavity. The perfluorocarbon evaporates on contact with the internal nares and base of skull, facilitating rapid and significant heat transfer. It is the first product with mild therapeutic hypothermia to effectively preserve the brain during cerebral ischemia events.

Indications: Cardiac arrest; stroke

CE mark received: 2011

Savene

Company: Onxeo

Product introduction: Savene® (dexrazoxane), developed by TopoTarget (Onxeo), is used for the treatment of anthracycline extravasation, a rare complication to chemotherapy. The product works by inhibiting DNA topoisomerase II, which is the target of anthracycline chemotherapy.

Launched year: 2006

Spacevision, C3, Ulis, Lumis, P.l.u.s, Flex2, UniThread

Company: SpineVision

Product description:

A series of innovative products which offer key advantages to surgeons and benefits to patients. SpineVision’s current products offer solutions for approximately 90% of spinal pathologies i.e. lumbar degenerative disc diseases, deformities, cervical disorders, trauma and tumors. With its new generation products Flex+2 and LUMIS SpineVision® is the only manufacturer offering a dynamic stabilization system which can be used in a percutaneous approach.

Thalomid

Company: Pharmion

Product introduction: Thalomid® (thalidomide) is an immunomodulator used to treat and prevent moderate to severe skin lesions caused by leprosy. The product is also used to treat multiple myeloma in combination with dexamethasone.

Launched year: 1998

Tracleer

Company: Actelion

Product introduction: Being the lead product of Actelion, Tracleer® (bosentan) – an endothelin receptor antagonist – was the first oral treatment approved for PAH.

Launched year: 2001

Translarna

Company: PTC Therapeutics

Product introduction: Translarma (ataluren) is a protein restoration therapy that treats Duchenne muscular dystrophy (DMD). The product was launched in Germany after conditional approval for marketing in the EU states was granted by the European Commission in August 2014. It is the first treatment approved for DMD.

Launched year: 2014

Uptravi

Company: Actelion

Product introduction: Uptravi is used to treat Pulmonary Arterial Hypertension (PAH).

Launched year: 2016

Veletri

Company: Actelion

Product introduction: Veletri® (Epoprostenol for Injection) is intravenous prostacyclin. Unlike other epoprostenol formulations approved for PAH, Veletri is stable at room temperature for up to 48 hours when administered immediately upon reconstitution and dilution, making the use of frozen gel packs unnecessary.

Launched year: 2010

Ventavis

Company: Actelion

Prodcut introduction: Ventavis® (inhaled iloprost) is an inhaled formulation of iloprost, a synthetic compound that is structurally similar to prostacyclin (PGI2) – a naturally occurring molecule that causes blood vessels to dilate, limits cellular hypertrophy, and inhibits platelet aggregation.

Launched year: 2007

Vidaza

Company: Pharmion

Product introduction: Vidaza® (azacitidine) is a pyrimidinenucleoside analog of cytidine which induces antineoplastic activity. The product is approved by the FDA and is indicated for the treatment of high-risk myelodysplastic syndrome.

Launched year: 2008

Vyzulta

Company: Nicox/Bausch & Lomb

Product description: VYZULTA™ (latanoprostene bunod) is a prostaglandin analog indicated for the reduction of intraocular pressure in patients with open-angle glaucoma or ocular hypertension.

Launched year: 2017

Wartec

Company: Conpharm

Product introduction: Wartec cream® (podofilox) is an over the counter topical solution formulated to treat genital warts that are found in the external genital region (penis or vulva) or around the anus, caused by human papillomavirus (HPV).

Launched year: 1999

Xofigo

Company: Algeta (Bayer)

Product introduction: Xofigo® (radium Ra 223 dichlorideis) is the first and only approved alpha particle-emitting radiopharmaceutical product for the treatment of castration-resistant prostate cancer with symptomatic bone metastases.

Launched year: 2013

Zavesca

Company: Actelion

Product introduction: Miglustat, the active ingredient of Zavesca®, is an orally available molecule with a large volume of distribution, which was developed for the treatment of type 1 Gaucher disease (GD1).

Launched year: 2003

Zephyr Endobronchial Valve

Company: Pulmonx

Indicator: Emphysema

MoA: Endobronchial valve (EBV) therapy based on Chartis treatment planning is an effective, minimally invasive method developed by Pulmonx to manage hyperinflation.¹ It is intended to predict and achieve reduction of volume in the diseased portion of the lung, without the risks and complications of surgery. EBV therapy involves an assessment of the patient’s hyperinflated lobes for the presence of collateral ventilation, or airflow within or between lobes of the lung, and then treating the patient by placing small, one-way valves in the targeted airways to direct the flow of air out of diseased portions of the lung. A typical procedure involves a Chartis assessment which typically takes about 5 minutes per lobe, and then placing three to four valves in the target lobe, which takes approximately 10 to 30 minutes to complete.

CE mark received: Zephyr® Endobronchial Valve 2003

Zephyr® Valve Delivery System

Company: Pulmonx

Indicator: Emphysema

Product Description: The Zephyr^® Endobronchial Valve is delivered to the target airway using a flexible delivery catheter which is inserted through standard bronchoscopes with a 2.8 mm or larger working channel, and 550 mm or 600 mm working length, depending on the manufacturer. Once positioned in the target bronchus, an actuator button on the catheter retracts the sheath, allowing the Zephyr^® valve to expand against the bronchial wall. A typical procedure involves placing approximately three to four valves to isolate the target lobe, and takes approximately 10 to 30 minutes to complete.

Zubsolv

Company: Orexo

Product introduction: Zubsolv® (buprenorphine and naloxone) sublingual tablet is indicated for treatment of adult opioid dependence. The product should be used as part of a comprehensive treatment plan, which includes counseling and psychosocial support.

Launched year: 2013