P03 - FAR 13.5 Sole Source Justification - Over SAT - 36C261-22-AP-2082 - Final -01_Redacted.pdf

DEPARTMENT OF VETERANS AFFAIRS

SOLE SOURCE JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL ITEMS IN

ACCORDANCE WITH FAR 13.5

Acquisition Plan Action ID: 36C261-22-AP-2082

1. Contracting Activity: Department of Veterans Affairs, Veterans Health Administration, Regional Procurement Office

West, Network Contracting Office (NCO) 21, for the Veterans Integrated Service Network (VISN), Palo Alto Health Care System, 3801 Miranda Ave. Palo Alto CA 94304.

2. Nature and/or Description of the Action Being Processed:

This procurement is for the NICO Myriad and Novus Brainpath System in accordance with FAR 13.5 Simplified Procedures for Certain Commercial Items and specifically FAR 13.501 Special Documentation Requirements, where acquisitions conducted under Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6, but still require a justification using the format of FAR 6.303-2.

This proprietary procurement is for a NICO Myriad and Novus Brainpath System. This is a system for brain tumor resection that uses a mechanical cutting device producing minimal heat. It minimizes trauma to the surrounding brain tissue for deep tumors and allows for minimally invasive cases. This will be highly beneficial to veterans undergoing such neurosurgery procedures as it minimizes trauma during the procedure.

This action shall be awarded as a new Firm-Fixed-Priced contract.

3. :

Estimated Dolar Value: $285,435.00

NICO Myriad NOVUS: A system consisting of a console, xenon light source, handpieces, and accessories that provides automated tissue removal and collection with illumination for minimally disruptive neurosurgical approaches. The NOVUS affords removal through automated, variable suction and cutting that has been shown to be safe and effective near critical structures. The suction is controlled by the surgeon and can range in equivalency from a size 3- 10 french suction tube, as needed, throughout the procedure. It is low profile, with a side-mouth aperture to allow for visualization of the tissue to be resected. The xenon light is at the distal end of the handpiece cannula to illuminate the surgical site. The tissue resected through the Myriad handpiece maintains its cellular viability and is collected in a preservation system at the end of the device for post-procedural analysis and/or oncological research efforts.

NN-7060 NICO Myriad Novus Capital Kit

NN-7044 NICO Brain Path 11mm & 13.5 mm Combo capital package

Disposibles:

4. Statutory Authority Permitting Restricted Competition:

FAR 13.5 Simplified Procedures for Certain Commercial Items. The statutory authority for applying the Simplified Procedures for Commercial Items of FAR 13.5 is 41 U.S.C. § 1901 and is implemented by FAR 13.106-1(b)(2) for restricting competition on this procurement. Competition is restricted on this procurement for the reason below:

( X ) Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements ( ) Unusual and Compelling Urgency ( ) Industrial Mobilization, Engineering, Developmental or Research Capability or Expert Services ( ) International Agreement ( ) Authorized or Required by Statute ( ) National Security ( ) Public Interest

5. Demonstration that the C Unique Qualifications or Nature of the Acquisition Requires the Use of the

Authority Cited Above (applicability of authority):

NICO Myriad and Novus Brainpath System This is a patented tool that achieves minimally-disruptive access using

-sulcal and parafascicular surgical approach. The equipment is also FDA approved.

The Myriad NOVUS has no direct competitors providing the same features and clinical benefits. The features that make the NOVUS unique from other devices include:

Non-heat generating Non-ablative, mechanical suction and cutting technology Proprietary linear and variable suction controlled by the surgeon, ranging in equivalency from a size 3-10 french suction tube.

Proprietary xenon light delivery direct to the surgical site Automates collection of resected tissue, ideal for post procedural analysis and oncological research initiatives.

Multifunctional in nature combining, xenon light, suction, scissors, blunt dissector, tissue collection and tissue preservation.

The advantages of this unique system listed above will be beneficial to our veteran patients. The following information is provided to show the statistical outcome with the use of the NICO Myriad & Novus Brainpath System.

ICH Evacuation Clinical Impact

Using a repeatable approach (trans-sulcal, parafascicular) and technology (BrainPath for access and NICO Myriad NOVUS® to mechanically evacuate the clot) provides three clinical advantages for ICH evacuation:

Intervention in an acute time period without clot stability1 Effective hemostasis management using a bi-manual technique Consistent evacuation >90% of clot1,2,3,4

Selected Clinical Outcomes

98.2% median clot evacuation1 mRS <3 in 63% of patients2 <15mL EOT volumes in 94 of 98 patients studied1,2,3,4 Statistically significant post-op GCS improvement1,3 Mortality Improvement (vs pre-op ICH score)1,3 Decrease in ICU length of stay from 12 to 4 days5 clinical evidence-for-ICH-evaluation-NICO

Selected Economic Outcomes

Increased surgical options for patients vs medical management.

Reduction in repetitive non-contrast CT scans.3 Throughput 55% decrease in mechanical ventilation days.3 18% decrease in neuro-ICU LOS days, freeing-up neuro-ICU beds.3 47% decrease in cost per patient.3

Tumor & Brain Biopsy Clinical Impact

In a 2020 Meta-Analysis published in World Neurosurgery that included 29 publications meeting rigorous inclusion criteria, more than 280 patients were included in a review of current studies on use of MIPS with BrainPath. The outcomes not only confirmed the success of non-disruptive, trans-sulcal access and the ability to achieve microsurgical techniques and hemostasis management, but also the following:

Selected Clinical Outcomes

Lower surgical morbidity / post-operative complications (8.3%) as compared to traditional craniotomy6 80.6% of cases achieved gross total resection6 100% gross total resection for colloid cyst6 100% success in achieving pathologic diagnosis for all biopsy cases6

Selected Economic Outcomes

Several cohorts have reported shorter length of hospital stay with MIPS using BrainPath as compared to traditional craniotomy, with benefits of:

Minimal wound disruption6 Decreased risk of post-operative wound infection6 Lower post-operative complications6

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

Contract Specialist posted a Notice of Intent to Sole Source, 36C26122Q0312, on Contracting Opportunities from 02/25/2022 03/04/2022 and received no responses.

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable:

The Contracting Officer will review and determine if the anticipated price is consdiered fair and reasonable. A FAR Part 13 Open Market Award Decision Documentation Form shall detail how the Government will determine that the anticipated cost is fair and reasonable. The basis of price reasonableness will be determined based on comparison with similar items in a related industry.

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research

Was Not Conducted:

Techniques Used in Conducting Market Research:

Market Research was conducted utilizing the following sources and techniques:

a. Posted a Notice of Intent to Sole Source on Contracting Opportunities

b. Reviewed Systems

Results of Market Research:

This proprietary procurement is for specialized surgical equipment to conduct brain turmor resections.

The NICO Myriad NOVUS is a powered instrument consisting of a console, handpieces, and accessories intended to perform resection and removal of soft tissue and fluids under direct visualization with or without magnification (e.g., loupes or microscope).

The results of the market research conducted concluded that there is only one (1) vendor that is exclusively authorized to manufacture and distribute the goods and services that meet the salient characteristic needs for VA Palo Alto. The manfacutre/vendor is a Small Businss under NAICS code 339112 and was verified in SAM. This NICO Corporation (DUNS No. 829838288) is a Small Business expiring on 10/25/2022.

9. Any Other Facts Supporting the Use of Other than Full and Open Competition:

VA Palo Alto Health Care System Chief of Neurosurgery conducted the research. The Chief has extensive experience in the Neurosurgery field and discussed with his colleagues both inside and outside the VA. Nico Corporation has been around since 2012 and is an established company. Through their process of continuous improvement and innovation, the U.S. Food and Drug Administration (FDA) in less than a 15-month period, granted a new and updated 510(k) clearance for two patented technologies made by NICO Corporation that are used in a new approach for brain surgery. Most recently, NICO received a new clearance for specific neurosurgical indications on its patented Myriad® automated tissue removal technology. The new clearance provides specific disease state approval for primary and secondary brain tumors, vascular abnormalities and malformations, and intraventricular tumors and cysts.