Current Projects

Pharmaceuticals

New FranceUSA CNS
Status
Vorpal is simultaneously proceeding with preparing orphan drug designation and clinical design for a childhood neurological disorder
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FranceUSA Oncology
Status
Vorpal is supporting orphan designation for anticancer drug
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FranceFRA OB/GYN
Status
Vorpal is starting a Phase I clinical trial for new drug in the women's health field
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Regenerative Medicine

FranceUSA Regenerative Medicine
Status
Vorpal is assisting multiple companies with partnering and business development in the regenerative medicine field
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Drug-Device Combination

New FranceUSA ENT
Status
Vorpal is managing all aspects of clinical, regulatory, new category reimbursement strategy and D-MAH services for an implant used in the treatment of chronic sinusitis
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USAUSA Hematology
Status
Due to a corporate spin-out, Client lost its qualified base in Japan and required Vorpal to take over all regulatory and reimbursement processes from previous management. After a smooth transition and proceeding ahead of schedule, we are initiating a clinical trial for this innovative device-drug system at 3 centers in Japan. Vorpal is also overseeing booth design for congress participation, surveying distributor reputations to aid in selection and hiring bilingual support staff on behalf of Client
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Medical Devices (Class IV)

New GermanyUSA Radiation Oncology
Status
Vorpal is managing all aspects of clinical, regulatory, new category reimbursement strategy and D-MAH services for an implant used in radiation oncology
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New FranceJPN Neuroradiology
Status
Vorpal is assisting the overseas expansion of a Japanese company specializing in Neuro Intervention
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New GermanyUSA Vascular Surgery / Interventional Radiology
Status
Vorpal is managing all aspects of clinical, regulatory, new category reimbursement strategy and D-MAH services for a device used in the minimally invasive creation of AV fistula
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GermanyUSA Cardiovascular
Status
Vorpal is developing a clinical trial strategy and go-direct marketing plan for a manufacturer of cardiovascular devices
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GermanyDEU Cardiovascular
Status
Vorpal is consulting on reimbursement strategy for a new cardiovascular device
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GermanyUSA Interventional Cardiology
Status
Vorpal is conducting market access research and managing all aspects of regulatory and reimbursement submissions. Vorpal will also partner with Client through commercialization, identifying a distribution partner and functioning as D-MAH
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USAUSA Ophthalmology
Status
Vorpal is securing Foreign Manufacturing site Accreditation as an initial step for an innovative implant used in ophthalmic surgery. The next steps will be reimbursement then direct distribution support as Client’s designated Marketing Authorization Holder
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Medical Devices (Class III)

New TWNTWN Ophthalmology
Status
Vorpal is handling the regulatory submissions and providing D-MAH services for contact lenses
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USAUSA Cardiovascular
Status
Vorpal is handling regulatory submissions for transcatheter device for DHF
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GermanyDEU ENT
Status
Vorpal is developing the regulatory and reimbursement strategy for an innovative ENT therapy with an orphan indication. Following launch, Vorpal will be Client's designated Marketing Authorization Holder and will manage direct distribution
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USAUSA Cardiovascular
Status
Vorpal is managing all aspects of regulatory, clinical and market development for a minimally invasive vascular access device
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SwedenSWE Neurosurgery
Status
Vorpal is handling all aspects of regulatory affairs for a cranial repair device
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FranceITA Dermatology / Plastic Surgery
Status
Vorpal is handling all aspects of regulatory affairs for dermatology treatment system
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USAUSA Dermatology / Plastic Surgery
Status
Vorpal is handling all aspects of regulatory affairs for dermatology treatment system
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FranceFRA Orthopedic Surgery
Status
Vorpal is handling all aspects of regulatory affairs and reimbursement for innovative implants and instrumentation used for orthopedic reconstruction
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  SwedenSWE Dermatology / Plastic Surgery
Status
Vorpal is managing all aspects of regulatory affairs and reimbursement. We are currently conducting a gap analysis of overseas data in order to formulate regulatory strategy for Client's innovative lineup of anti-microbial products
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USAUSA Psychiatry
Status
Vorpal is managing all aspects of regulatory affairs and reimbursement for an innovative capital equipment system used in the treatment of psychiatric conditions. We are currently preparing for regulatory filing based on overseas clinical trial data, and working with KOLs and Associations to lay the groundwork for favorable reimbursement. Post-launch, Vorpal will be working with a known distributor as designated Marketing Authorization Holder
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Medical Devices (Class II)

New FranceFRA Software
Status
Vorpal is providing D-MAH services for diagnostic imaging analytical software
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New USAUSA Dental
Status
Vorpal is managing regulatory and D-MAH services for an orthodontic appliance
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New IsraelNLD Software
Status
Vorpal is providing D-MAH services for diagnostic imaging analytical software
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IsraelNLD Cardiovascular
Status
Vorpal is handling regulatory submissions for software used in the diagnosis and treatment planning for cardiovascular disease
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IsraelUK Surgical System
Status
Vorpal is handling all aspects of regulatory affairs for an endoscopic surgery device
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IsraelSWE Pulmonology
Status
Vorpal is handling all aspects of regulatory affairs for an organ preservation device
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IsraelISR Cardiology
Status
Vorpal is working with overseas and Japanese doctors to finalize the protocol for a clinical study to demonstrate efficacy of a novel ischemic heart disease diagnostic technology. Following clinical results, we will manage regulatory and reimbursement submissions. Vorpal will be Client’s designated Marketing Authorization Holder and will also manage distribution in both reimbursed and self-pay segments
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IsraelISR Critical Care
Status
Vorpal is acting as designated Market Authorization Holder and is collaborating with distributors for an innovative cardiac monitoring system
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Medical Devices (Class |)

New IsraelNLD Radiation Oncology
Status
Vorpal is handling regulatory affairs for disposable medical devices used in radiation oncology
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New FranceUSA Emergency Medicine
Status
Vorpal is handling the regulatory submission and D-MAH services for a hemostatic dressing
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FranceUSA OB/GYN
Status
Vorpal is handling all aspects of regulatory affairs for Manual Vacuum Aspiration system
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