6515--Orthopedic and Podiatry clinics; Ossatron Treatments

Intent to Sole Source 36C24721Q1122. This is an Intent to Sole Source, this is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to provide information based on this requirement. The Department of Veterans Affairs, NCO 7 Regional Procurement Office - East on behalf of the VA Augusta, GA intends to award a Firm-Fixed-Price sole source award to Premier Shockwave, Inc. for the to provide an OssaTron medical device, consumables, and technician for Plantar Fasciitis, Achilles Tendonitis, Lateral Epicondylitis, Patellar Tendonitis, Tricep Tendonitis, Metatarsalgia and other indicated procedures. The Orthopedic and Podiatry clinics treat patients suffering chronic pain from various tendinopathy conditions that are currently being managed by pain medications. One of the doctors has experience with the use of high- energy electro-hydraulic extracorporeal shockwave device (OssaTron) and found it to be effective in treating these conditions. This sole source award to Premier Shockwave, Inc. is in accordance with 41 U.S.C. 3304 as implemented by way of the procedures outline in the Federal Acquisition Regulation (FAR) subpart 6.302-1 Only one responsible source and no other supplies or services will satisfy agency requirements. This is not a request for competitive offers, quotes, or capability statements. No solicitation will be posted as a result of this notice. This Special Notice is being issued for information purpose only. NAICS:334510 , SBA Size Standard: 1250 Employees, PSC: 6515. END OF INTENT TO SOLE SOURCE. All sources eligible to meet this requirement must respond in writing and challenges to this Intent to Sole Source shall be sent to Darlene.Chase@va.gov no later than 11:00AM EST on August 11, 2021, if no responses are received by 11:00AM EST on August 11, 2021 to demonstrate comparable capability, then a sole source acquisition award will be made.

DEPARTMENT OF VETERANS AFFAIRS

Justification and Approval (J&A) For

Other Than Full and Open Competition (>SAT)

Acquisition Plan Action ID:

Contracting Activity: Department of Veterans Affairs, VISN 7, Charlie Norwood VA Medical Center, Augusta GA, 30904.

Nature and/or Description of the Action Being Processed: This is a new firm-fixed price contract to obtain the use of high-energy electro-hydraulic extracorporeal shockwave device that is FDA Approved to treat multiple tendinopathies: Plantar Fasciitis, Achilles Tendonitis, Lateral Epicondylitis, Patellar Tendonitis, Tricep Tendonitis, and Metatarsalgia.

Description of Supplies/Services Required to Meet the Agency s Needs: The vendor will provide an OssaTron machine and all consumables required to perform tendinopathy procedures to treat Veteran s suffering chronic pain from Plantar Fasciitis, Achilles Tendonitis, Lateral Epicondylitis, Patellar Tendonitis, Tricep Tendonitis, and Metatarsalgia. The OssaTron device is the only high- energy electro-hydraulic extracorporeal shockwave device that is FDA Approved to treat chronic plantar fasciitis & chronic lateral epicondylitis. This is the only device that can be used by Orthopedists & Podiatrists to perform these procedures. There are two types of tendinopathy procedures that will be performed Bilateral and Unilateral. The hospital estimates it will need to perform 94 Bilateral procedures and 98 Unilateral procedures

a piece for an estimated contract cost of per year. The procedures will be performed over a 12-month period from the award date of this contract and include 4 option years

over 5 years.

Statutory Authority Permitting Other than Full and Open Competition:

(X) (1) Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements per 41 USC §3304(a)(1) as implemented by FAR 6.302-1;

( ) (2) Unusual and Compelling Urgency per 41 USC §3304(a)(2) as implemented by FAR 6.302-2; ( ) (3) Industrial Mobilization, Engineering, Developmental or Research Capability

or Expert Services per 41 USC §3304(a)(3) as implemented by FAR 6.302-3;

( ) (4) International Agreement per 41 USC §3304(a)(4) as implemented by FAR 6.302-4

( ) (5) Authorized or Required by Statute per 41 USC §3304(a)(5) as implemented by FAR 6.302-5; ( ) (6) National Security per 41 USC §3304(a)(6) as implemented by FAR 6.302-6;

( ) (7) Public Interest per 41 USC §3304(a)(7) as implemented by FAR 6.302-7;

FAR13.5 Simplified Procedures for Certain Commercial Items: N/A

Demonstration that the Contractor s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority): Premier Shockwave Inc., is the only source that provides mobile OssaTron devices to hospital and doctor offices nationwide. Through a series of transactions, Premier Shockwave has purchased 70 of the 72 OssaTrons that

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were brought legally into the United States. The company that produced the devices went bankrupt in 2005 and no longer produces the devices. There is not a substitute product capable of providing the treatments the OssaTron devices provide and there is no manufacture producing this machine or any comparable product. Premier Shockwave must sole source all replacement and consumable parts to keep their devices working at OEM specifications. The use of the OssaTron device is the most effective treatment found to treat plantar fasciitis, tennis elbow, patellar/achilleas tendonitis and is essential to provide treatment and relief to the veterans suffering from these conditions.

Accordingly, Premier Shockwave Inc. is the only firm capable of providing the supplies and services described in Section III above without the Veteran s Health Administration experiencing substantial duplication of cost that could not be expected to be recovered through competition

Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable:

Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: Premier Shockwave Inc. is the only provider of this service and has not raised their prices for services since 2008 thus the price being offered is considered fair and reasonable

Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted: Based on past knowledge of performing these procedures and recent web searches for additional sources has determined there is only one commercially available source for portable OssaTron Treatments. Premier Shockwave Inc. is the only known vendor in the United States that has high-energy electro-hydraulic extracorporeal shockwave devices capable of meeting the government s needs. They have an active registration with System for Award Management as a small business with no other socio-economic status listed.

Any Other Facts Supporting the Use of Other than Full and Open Competition: Premier Shockwave Inc., is the only source that provides mobile OssaTron, there is no other vendor capable of meeting the government s needs.

Listing of Sources that Expressed, in Writing, an Interest in the Acquisition:

Premier Shockwave Inc. 3360 Martin Farm Road, Suite 100B Suwanee, GA 30024,

A Statement of the Actions, if any, the Agency May Take to Remove or Overcome any Barriers to Competition before Making subsequent acquisitions for the supplies or services required:

Until a manufacture begins producing additional OssaTron devices or an acceptable replacement capable of providing Bilateral and Unilateral Tenopathy procedures there is not a way to overcome this competition barrier. Since no other sources are available to provide this treatment, we are requesting option years be provided for this contract.

Requirements Certification: I certify that the requirement outlined in this justification is a Bona Fide Need of the Department of Veterans Affairs and that the supporting data under my cognizance, which are included in the justification, are accurate and complete to the best of my knowledge and belief.

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