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TM Clinic Suite Value Proposition

MusicGlove Value Proposition - · PDF fileThese gains were retained at a long term follow-up. ... Damaged or short shipments should be reported within 5 days of receipt ... MusicGlove

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TM

Clinic Suite

Value Proposition

Overview:

Value of MusicGlove Therapy:

2015 Flint Rehabilitation Devices LLCC

MusicGlove is an innovative new hand rehabilitation device that has been clinically proven to improve functional outcomes and patient satisfaction for hand therapy after neurologic injury. It is a sensorized glove that promotes a high number of repetitions of functionally meaningful finger and thumb exercises through an immersive music-based game.

• Improve clinical outcomes through high intensity training Two randomized controlled trials performed at the University of California, Irvine showed that people using the MusicGlove had significantly greater improvements in hand function than those who performed conventional tabletop exercises. These gains were retained at a long term follow-up. See Appendix A for more information.

• Treat more patients without increasing staff MusicGlove offers a motivating alternative to conventional one-on-one therapy. The software includes a self-directed 15 to 60 minute Session Mode that can be used to increase the dose of intensive therapy each patient receives without the need for increasing staff. No additional training is required!

• Provide objective outcome measures for hand therapy MusicGlove also comes with a proprietary Analytics Suite that tracks and logs detailed measures of patient performance. With the touch of a button, therapists can view or print a patient’s historical data in a clear, concise format. Peer-reviewed studies have shown that the MusicGlove scores are highly correlated with established clinical measures of hand function, so these scores can also be used as an outcome measure for therapy.

• Reach a broad patient population MusicGlove can be used right away by any qualified patient—no custom fitting is necessary. The device caters to a wide spectrum of patients, from those with little residual finger movement to those who are almost fully recovered. The difficulty and intensity of the therapy can be quickly adjusted by changing the number and type of grips required during gameplay or by selecting faster or slower songs.

MG Clinic Suite

Tabletop Workstation Portable Workstation

Available Options:

Price:

2015 Flint Rehabilitation Devices LLCC

If you would like to purchase or include the 21” Flint Workstation, please add $700 to the Package Price.

MusicGlove comes with either a Tabletop or a Portable Workstation. The Tabletop Workstation is a 21’’ all-in-one touchscreen unit for clinics that want a dedicated MusicGlove workspace. The Portable Workstation is a 10’’ touchscreen tablet for clinicians who want to be able to easily move the MusicGlove from one location to another. The Portable Workstation is also available for home use so that patients can continue therapy after discharge.

Refer to the chart below for baseline pricing information. Please speak to one of our sales representatives at 1 (800) 593-5468 for information regarding purchases of multiple products.

Item Contents Price

Single Unit 1 MusicGlove, 1 pair headphones, accessories, 10” Flint Tablet with MusicGlove software (single user)

$1,099

2 Glove Pack

MG Clinic Suite2

MG Clinic Suite

2 MusicGloves (left/right; any size), 1 pair headphones, accessories, 10” Flint Tablet with MusicGlove software (multi user)

$1,999

4 MusicGloves (left/right; any size), 1 pair headphones, accessories, 10” Flint Tablet with MusicGlove software (multi user)

$2,999

6 MusicGloves (left/right; small/medium/large), 1 pair headphones, accessories, 10” Flint Tablet with MusicGlove software (multi user)

$3,999

Additional Song Expansion Packs

4 Additional Songs (one difficulty level) $40

12 Additional Songs (all three difficulty levels) $100

MG Home Suite

6 Glove PackMG Clinic Suite

4 Glove PackMG Clinic Suite

Frequently Asked Questions about MusicGlove Therapy:

2015 Flint Rehabilitation Devices LLCC

Who is the MusicGlove for? MusicGlove is intended for use by individuals with mild to moderate hand impairment after stroke, spinal cord injury, traumatic brain injury, or other neurologic injury to improve hand dexterity and strength. A qualified user should be able to touch their thumb to the index or middle finger and release this grip by a 1/4" or more. Is any special training required? The MusicGlove is ready for use right out of the box with no special training required. The entire unit takes less than 5 minutes to set-up and is designed to be user & clinician friendly. Is this a Covered Service? MusicGlove Therapy can be billed as neuromuscular reeducation or as a therapeutic procedure/exercise (ie: CPT codes 97112 and 97110). What songs are available? Our current playlist includes unique songs from a variety of genres (jazz, folk, pop). We are always expanding our playlist, and additional song packs will periodically be released. Can multiple patients use the same MusicGlove device? Yes, the clinic suite comes with 6 gloves that will accommodate all adult hand sizes. The software allows an unlimited number of unique user accounts to be created, so each patient’s performance can be recorded individually. How is the MusicGlove cleaned? The MusicGlove is manufactured with medical grade hard wearing fabric that is anti-microbial and anti-fungal. Finger cots on each glove are easily reversible and can be cleaned with the included alcohol wipes or with a disinfecting wipes appropriate for skin contact. Refer to Appendix B for the cleaning procedure. Where can I purchase the MusicGlove? Flint Rehabilitation Devices is the sole distributor of the MusicGlove in the United States. See terms and conditions for purchasing information. Can I purchase an extended warranty? An additional 1 year warranty for a total of 2 years of coverage can be purchased for 15% of the final sales price. Where was the MusicGlove developed and where is it manufactured? MusicGlove was originally developed by a team of researchers and engineers at the University of California in Irvine. The device is manufactured in Southern California.

Comparison Chart of Hand Rehabilitation Devices

About the Company:

2015 Flint Rehabilitation Devices LLCC

MusicGlove SaeboFlex Bioness H200 Suitable for clinic use

Suitable for home use

No electrical shock

Easy to use

Promotes high number of repetitions

Tracks improvements in hand function

Trains thumb opposition

Trains finger individuation

Can be used with multiple patients

Engaging game interface

MSRP $1,099 $1,690 $6,200

Flint Rehabilitation Devices, LLC is a medical manufacturer and distributer that specializes in innovative rehabilitation devices for neurologic and muscular disabilities. The company is committed to developing and selling high quality, interactive, and engaging rehabilitation tools that improve outcomes and increase patient satisfaction. Flint leverages close ties with leading research institutions to commercialize and sell cutting edge technology in the field of rehabilitation.

Flint is a licensed medical device manufacturer by the Food and Drug Branch of the California Department of Public Health and is registered with the U S Food and Drug Administration. The company is located in Irvine, California and is a registered Limited Liability Company. Flint is the exclusive retailer/distributor of all non-government purchases in the U.S. All government contracts using GSA are handled through medical distributor Best Priced Products. Aroga Technologies is the exclusive distributor of the MusicGlove in Canada for government and non-government purchases.

Terms and Conditions

1. General The following Terms and Conditions shall apply to all contracts for the sale of any articles (“Goods”) supplied by Flint Rehabilitation Devices, LLC (“Flint”) to any organization who buys Goods from Flint (“Buyer”). Any variation to these Terms and Conditions (including any special terms and conditions agreed to by both parties) shall be inapplicable unless agreed to in writing by the Seller. 2. How to Order The Buyer can order Goods from Flint by Phone, Fax, Mail, Email, or directly on Flint’s website.

• Phone – 1 (800) 59-FLINT, our Customer Service Representatives are available Monday through Friday, 9:00 a.m. to 5:00 p.m. PST.

• Fax – (949) 419-1394, 24 hours a day, 7 days a week. • Mail – Flint Rehabilitation Devices LLC, 18023 Sky Park Circle, Suite H2, Irvine, CA 92614 • Online at http://www.flintrehab.com

3. Payment Methods The following payment methods may be used:

• Credit Card – We accept Visa, MasterCard, Discover Card and American Express. If you are charging your order, include the name, number and expiration date as they appear on the charge card, and the billing address as it appears on the billing statement.

• Checks/Money Orders – Mail your check/money order made payable to Flint Rehabilitation Devices, LLC. Include tax (if applicable). See remittance address below.

• Purchase Orders – A Sales Representative can provide you with a Sales Quote. Once signed, fax or e-mail this form to [email protected]. A bill for the described items will be sent once the quote is confirmed. If you use a Purchase Order, be sure to indicate your billing address, shipping address (if different) and phone number.

4. Payment Terms Terms are Net 30 days. Invoices that are not disputed within 30 days are considered to be accurate and accepted. Overdue invoices are subject to the maximum allowable interest charges. Send all remittance to:

Flint Rehabilitation Devices LLC 18023 Sky Park Circle, Suite H2 Irvine, CA 92614

Returned checks are subject to a $35.00 fee.

5. U.S. Shipping, Handling & Delivery Flint will cover ALL costs of shipping, handling & delivery. United Postal Service (UPS) is our shipping courier. Please allow 10-15 business days for the item to arrive at your location. The contact listed on the Invoice/PO will receive an email confirmation once the product has been shipped. This email will include your Shipping Tracking Number.

6. Damaged Goods Damaged or short shipments should be reported within 5 days of receipt via phone or email. If a shipment arrives damaged or if the box appears damaged, Flint will supply a return label for the damaged goods and promptly replace the items. Please note damage on the delivery bill and have the driver sign it, acknowledging the damage. Save the damaged packaging and merchandise for inspection by Flint.

2015 Flint Rehabilitation Devices LLCC

7. Returns Procedure In the event a return of the Goods is required and covered under the Terms and Conditions described in this document, please use the following procedure to initiate the process:

1) Call our Customer Service Department (CSD) at 1 (800) 59-FLINT, Monday through Friday from 9:00 a.m.-5:00 p.m. PST. Our CSD will provide you with a Return Merchandise Authorization and a Return Shipping label for any items you wish to return via email or US Mail.

2) Within 5 business days of receiving the Shipping Label, please send all Goods to be returned to Flint Rehabilitation Devices LLC, 18023 Sky Park Circle, Suite H2, Irvine, CA 92614. Note, Goods will only be accepted for return if a Return Merchandise Authorization is included in the return package.

3) All return shipping expenses are paid by Flint Rehabilitation Devices LLC. Items must be returned within 30 days of receiving.

4) All Goods must be returned in Like New condition. The Buyer is responsible for properly packaging and protecting the item during shipment to Flint Rehabilitation Devices, LLC. Goods that are not in Like New condition will be subject to a 15% restocking fee.

8. Limited Warranty This warranty is extended only to the original purchaser who purchases this product when new and unused from Flint or a dealer. The warranty is not extended to any other person or entity and is not transferable or assignable to any subsequent purchaser or owner. Coverage under this warranty will end upon any such subsequent sale or other transfer of title to any other person. This warranty give you specific legal rights and you may also have other legal rights which vary from state to state. Flint warranties all components of this product when purchased new and unused to be free from defects in materials and workmanship for a period of one (1) year from the date of purchase from Flint or a dealer, with a copy of the seller’s invoice required for coverage under this warranty. The comprehensive warranty covers all components of the system including hardware, software, and firmware. If within such warranty periods any such product shall be proven to be defective, such product shall be repaired or replaced, at Flint’s option. This warranty includes labor, materials, and shipping charges incurred in replacement or repair of the product. Flint’s sole obligation and your exclusive remedy under this warranty shall be limited to such repair and/or replacement. Limitations and Exclusions: The foregoing warranty shall not apply to products subjected to negligence, accident, improper operation, maintenance or storage, products modified without Flint’s express written consent including, but not limited to, modification through the use of unauthorized parts or attachments; products damaged by reason of repairs made to any component without the specific consent of Flint, or to a product damaged by circumstances beyond Flint’s control, and such evaluation will be solely determined by Flint. The warranty shall not apply to failure to adhere to the product instructions.

9. Extended Warranty An additional 1 year warranty can be added to your order for 15% of the total product price.

10. Product Technical Support Flint provides lifetime product and technical support to the original purchaser. Support is available during Flint’s regular business hours. 11. Sales Tax & Exemptions If the facility receiving the merchandise is in a state or locality that normally charges tax, and you are exempt from tax, include a copy of your exemption or resale certificate with your payment or fax to: (949) 419-1394. Your sales tax will then be credited and exempt for all future orders. If your facility is not in such a state or locality, please submit use tax directly to your state.

2015 Flint Rehabilitation Devices LLCC

12. Pricing Prices given to the Buyer by our Sales Representatives on official Flint Letterhead apply only to the healthcare professionals and institutions to which the document was addressed. Individual product prices are available online at www.flintrehab.com and are subject to change without notice. Bulk purchasing options are available for qualifying healthcare facilities and institutions. 13. Consumer-Direct Orders Items are available to patients for direct purchase through Flint Rehabilitation Devices LLC. Order can be placed by telephone at 1 (800) 59-FLINT, Monday through Friday from 9:00 a.m.-5:00 p.m. PST. Consumers may also order online at: www.flintrehab.com 14. New Product Ideas If you have an idea for a new product, or a recommendation for a current product we’ll be happy to consider it. Please e-mail us at: [email protected] 15. Governing Law These Terms of Service and any separate agreements whereby we provide you Services shall be governed by and construed in accordance with the laws of the State of California without regard to its conflict of laws rules. (Each purchaser will edit the 'State') 16. Changes to Terms of Service We reserve the right, at our sole discretion, to update, change or replace any part of these Terms of Service by posting updates and changes to our website. You may request the most current version of this document by emailing us at [email protected]. 17. Contact Information Questions about these Terms and Conditions should be sent to [email protected].

2015 Flint Rehabilitation Devices LLCC

Appendix A: Clinical Efficacy

The MusicGlove is based on the latest rehabilitation research which has shown that therapy programs should:

1

2

3

1. Lohse et al, Stroke 2014; 2. Lo et al, NEJM, 2010; 3. Dobkin et al, NNR, 2010; 4. Safranek, Music Therapy, 2011; 5. Brochard et al, Crnt Opin Neurology, 2010; 6. Friedman et al, Intl Conf IEEE EMBS, 2011; 7. Friedman et al, JNER, 2014; 8. Zondervan et al, Pending publication

Require a large number of practice repetitions

Provide detailed feedback on progress over time

1

2

3

Challenge each patient at an individually appropriate level

Use music and video games to motivate patients and stimulate neural recovery.4 4BA

CK

GR

OU

ND

Clinical feasibility study comparing MusicGlove score to level of impairment (n = 10)

MET

HO

DS

RES

ULT

S

Clinical RCT comparing MusicGlove Therapy to Conventional Therapy (n = 12)

Home-based RCT comparing MusicGlove Therapy to Conventional Therapy (n = 17)

5

6

7

8

Study 1:

Study 2:

Study 3:

MusicGlove

Box

& Bl

ocks

Sco

re

Control

10

8

6

4

2

0

-2

-4

-6

Clinical StudyHome Study

In the initial feasibility study of the MusicGlove, researchers found that the percentage of notes hit in the MusicGlove game is strongly correlated with functional ability. This means users can set meaningful goals with the MusicGlove and receive real rewards when they achieve them.

In the second clinical study, researchers found that 6 one-hour therapy sessions with the MusicGlove lead to significantly greater improvements in hand function than a matched dose of conventional tabletop therapy for individuals with chronic stroke (blue bars, p = 0.01).

Similar results were found in the controlled study of self-guided therapy with the MusicGlove at home (orange bars, p = 0.05). Participants in both studies also reported regaining the ability to button up a shirt, type on a computer, feed themselves independently, etc. These improvements are most likely due to the large number of repetitions (>5000) patients performed during their therapy.

1

2

3

2015 Flint Rehabilitation Devices LLCC

Appendix B: Cleaning Procedure

2 Flip finger cots inside-out and wipe down glove with included alcohol pads

or disinfectant wipes.

3 Put on therapeutic glove.

4 Clean hands after removing therapeutic glove.

Developed by:Debbie Thompson RN, CICEpidemiology and Infection Prevention

UC Irvine Health200 S. Manchester Avenue, Suite 100 | Orange, CA 92868

Tele 714-456-8952Fax 714-456-2252Pager 714-506-0619

5 Flip finger cots inside-out and wipe down glove with alcohol pads or

disinfectant wipes.

1 Patient clean hands with soap and water or waterless hand rub.

2015 Flint Rehabilitation Devices LLCC