Cala Trio™ makes it simple.

Learn more about this individualized wrist-worn neuromodulation therapy that effectively reduces hand tremors.

Benefits for you and your patient
performance icon 68%

68% (BF-ADL) of patients improved from ‘Severe’ or ‘Moderate’ tremor at the beginning of the study to ‘Mild’ tremor as reported by patients.

Drug-free

Tremor reduction without systemic side effects.

performance icon 54%

54% of patients improved by 50%

Learn more about
the Cala Trio therapy

For the visually impaired, a full text alternative of this video is available here

AUDIO / VO VISUALS NOTES

1

Music Over

Opening bumper

Cala Trio logo and tag

"Hands" opening sequence - Last shot of animation locks to first shot of incoming scene.

2

VO:

"Essential tremor is a benign yet life-altering condition that impairs performing day to day activities. Although onset typically occurs of essential tremor typically occurs in adults 50 and older, symptoms may appear much earlier in life.

Music under

Title – Understanding Cala Trio. A breakthrough individualized therapy for essential tremor

Shots of (2) tremor patients trying to do tasks untreated – frustrated. Nothing is easy.

Condensed Intro from Product Hero Video including shots of tremor patients trying to do tasks untreated that follows VO.

3

VO:

"A majority of essential tremor patients exhibit postural and kinetic tremor in the upper limbs. In some cases, patients may exhibit tremor of the head, face, voice, trunk or lower limbs."

MCU patient hands w/ tremor

OR a Grey's anatomy showing where on the body tremor can affect

4

VO:

"The exact pathogenesis of essential tremor is unknown. It may be a result of a complex neural involving multiple structures in the cerebellum, basal ganglia, and cortex. Deep brain structures, such as the ventral intermediate nucleus—or VIM—of the thalamus, are also considered relay points in this network."

Music under

Animation – Follow VO

Stylized animation showing the VIM region in the Brain

Close-up's or call-outs for details on specific areas and functions highlighting the relay points to the neural network

Details, text call-outs, and other supporting GFX to follow VO

5

VO:

"Evidence has shown that Invasive brain surgery that targets the VIM, including deep brain stimulation and thalamotomy procedures has been effective in treating essential tremor symptoms. But for most physicians and patients a less invasive and lower risk option has always been desired"

Show images of scientific journal quotations that support the efficacy of invasive stim – news headline style?

6

VO:

"Now from Cala Health, A breakthrough treatment of essential tremor is here.

Introducing Cala Trio, a non-invasive option specifically designed to target the tremor network with peripheral nerve stimulation through the wrist.

Surface stimulation is delivered to the median and radial nerves disrupting the pathological tremor frequency signals. This effectively addresses the variability of your patients condition resulting in a meaningful reduction of the tremor a period of time"

Music under

Live action to animation (composite)

Patient at home in background… Trio sits on table in foreground. Patient walks up (into focus) and puts it on…

Sits...

CU - Show pressing start button and lines simulating stimulation up the arm in bursting pattern

MED - Show stimulation (2 lines traveling up the arm to the brain). Show region of the nerve location on the wrist shaded and brain (suggesting target zone).

Action, pacing and GFX support follow VO

Shoot 4k – zoom in to focus on details

7

VO:

"Cala Trio provides on-demand tremor relief after a 40 minute stimulation session.

In a controlled clinical trial, 62% of patients experienced meaningful symptom improvement using Cala Trio therapy at home.

68% of users reported improvement in activities of daily living. Most notably in handwriting, holding a cup, and using a spoon.

Users that experienced benefit reported tremor relief lasting up to an hour and a half following therapy.

The most common reported side effect in the study was mild to moderate skin irritation, including electrical stimulation burns, redness and/or itching"

Info – graphics over outgoing scene

Video of 1 pre & post postural task from TETRAS comparison segment. (Condensed; don't show data on left)

Then

Graphically show 3 semi-circles of the key statistics the VO is stating (75%, 78%, 48%) with "TETRAS rating by blinded physicians"

Text on screen bottom

A 3% mild adverse event rate across treatment and sham groups included skin irritation. This resolved within 24 hours without treatment or sequalae.

May also have publication credit across the bottom of the screen as required

8

VO:

"Essential tremor is a progressive and clinically heterogeneous condition with sporadic and familial forms. Tremor amplitude increases with age. Accounting for substantial disability in older people. Understandably the magnitude of response varies in patients using Cala Trio."

Animation

Show oscillations graphically from accelerometer at the bottom of the screen while a patient does a postural hold

Cala clinical science team is working on how we want to show this and describe the variable response

9

VO:

"on average a 49% reduction in tremor amplitude is demonstrated. However some patients have greater than an 80% reduction. Use of the device is the best way to asses if Cala Trio is effective for any individual patient.

With Cala Trio, therapy is calibrated to the patient's specific tremor motion by performing tremor tasks for 20-second.This only needs to be performed the first time the device is used.

The accelerometer inside Cala Trio will measure the frequency of the patient tremor across 3 axes.

During therapy, patterned stimulation to the median and radial nerves is delivered at the patient's tremor frequency."

Music under

Outstretched hands in postural hold with device on; patient is doing this alone in a home environment

CU show ‘measurement stored' screen.

Then show patient starting therapy and the animation of the stimulation traveling up the arm in 2 lines or 2 waves

small text on screen:

Cala Trio can be recalibrated as needed.

10

VO:

"Traditionally, stimulation products used on skin use hydrogel electrodes that can only be applied once and leave a sticky residue."

A proprietary electrode has been created for Cala Trio. This allows multi-day wear of the electrodes. The Cala Trio band can be used for 90 days which improves the user experience of traditional hydrogel electrodes.

"The device monitors days of use and will remind the patient to change their band."

Visual: a picture of traditional sticky hydrogels being peeled off the skin

Close up of electrode on Cala Trio Band with live action of the patient putting on the device

Or image of the electrodes close-up and then live action to the device on a patient's wrist

CU "replace band" screen

Text on screen sync'ed with VO saying one month:

Bands are worn for 1 month

11

VO:

"The device has a battery that provides at least 5 stimulation sessions between charging.

The base station is magnetized making it easy for users with essential tremor to secure it into place.

Cala Trio should be stored in the base station when not being worn."

Visual of charging base on a table with cord plugged into the wall

The stimulator attached to a band being slid down into charging opening. (slow mo or graphics to represent magnetic effect??)

CU charging screen of the device

12

"Cala Trio requires a physician's prescription.

Prescription forms can be downloaded from the Cala Trio website.

There are 3 important elements of the prescription

First, the device is unique to the patients right or left-hand. In order to match the anatomical nerve locations in the wrist.

Second, various sizes are available to ensure proper fit. So that stimulation is delivered to the target nerves

Lastly, prescribers select the tremor-inducing task which elicits the maximum tremor. This information ensures the calibration step is optimized."

Live action MD prescribing the device for a patient in a clinic setting

Show the prescription form

Photo of left and right-handed devices placed on two wrists correctly - overlay reinforcing the large button is towards the elbow

Text on screen to match VO:

3 elements of the prescription

  1. Small, Medium, or Large wrist
  2. Right/Left Hand
  3. Tremor Inducing Task Selection

Prescription forms available at http://www.CalaTrio.com/HCP

Cala Trio Therapy is a contraindicated for patients with cardiac pacemaker, implanted defibrillator, or other implanted electronic device, or implanted metal in the wrist.

13

VO:

"once the prescription is processed, the cala trio is shipped directly to your patients home with complete instructions. Prescribers may opt to have the device shipped to their office for therapy initiation./p>

The Cala Health Customer Success team is available to answer all of your patients questions"

Live action - Patient receives package

Show patient opening a door at home and being handed their Cala Trio package, then sitting at a desk setting it up

Patient on phone visual if time allows

14

VO:

"A breakthrough in care is here. Specifically designed for your patients with essential tremor. Providing on demand and individualized treatment. Cala Trio allows patients to activate their therapy, when and where they need it, without systemic side effects or drug interactions.

Inspire more present moments, welcome more meaningful engagements, and deliver better outcomes to your essential tremor patients with Cala Trio therapy."

Collage of live action shots of patients living their fullest life wearing Cala Therapy

15

Music under

Sting or Fade Out

Close with Cala Trio logo and the tagline

"Freedom to Be"

Bottom Disclaimer:

Caution: Federal law restricts this device to sale by or on the order of a physician.

Please refer to the labeling for a complete list of warnings, precautions, and contraindications.

Engineered by Cala Health www.CalaTrio.com 1-888-699-1009

FDA Cleared

Read the Clinical Research to learn more about how Cala Trio can help patients with essential tremor.

fda logo

Cala Trio is cleared by the FDA as a Class II Medical Device as an external upper limb tremor stimulator. The De Novo number is DEN170028 with subsequent 510K, K182706, and K203288.

01
Review indications
for use and contraindications

Indications for Use: To aid in the temporary relief of hand tremors in the treated hand following stimulation in adults with essential tremor (ET)

Schedule an In-service
to learn more
02
Choose which
hand to treat

Cala Trio is designed to stimulate nerves in the left OR right wrist. Device is not interchangeable. With your patient, decide on which hand to use the device to provide the most relief for their lifestyle.

03
Measure
wrist size.

Fit and placement of the Cala Trio are essential to therapeutic efficacy. Read tips to measure wrist when the patient is self-measuring or if the measurement tool is not available, read tips here.

04
Select
tremor task.

The “tremor task” is a postural hold that is repeated to characterize the patient’s tremor. Advise the patient that this specific “Tremor Task” will be performed when the device prompts them for a tremor task. Assess both tasks and choose the more severe postural hold.

05
Download the Cala Trio Prescription Form interactive PDF to your computer

Download now Once you download the Cala Trio
Prescription Form to your computer, you can save your Prescriber information at the top of the Cala Trio Prescription Form to save time when writing multiple RXs.

The Cala Trio Prescription Form PDF has a digital signature option Fax the completed and signed Cala Trio Prescription Form to Sfax (833) 230-9251 or Fax (650) 729-1156

Request
Prescription Kit
Like a specialty pharmacy,
Cala™ Customer Success
supports your patient!
arrow
Getting to know them Initial outreach

After receiving your patient’s prescription, Cala Trio Customer Success reaches out to your patient by phone within 48 hours. We answer all their questions to help them understand and manage their therapy including the cost of the therapy. Finally, we arrange access & delivery of therapy.

arrow
staying in touch Ongoing support

As a connected therapy, Customer Success partners with your patient on an on-going basis. We check in with your patient to help them figure out how Cala Trio therapy best fits into their life. We learn how they want to manage their tremor as part of their overall health. Then, we share our expertise to help identify the best practices that make sense to achieve their goals.

Yes; the performance of the band deteriorates with exposure to dry skin, skin oils, and dust. Over the course of months, the band is eventually unable to support effective therapy. Cala Trio informs the user five days before a band needs to be replaced. Cala Health automatically supplies Cala Trio patients with one band every three months to maintain effective therapy.

Like a specialty pharmacy, Cala Trio Customer Success supports your patient throughout their use of therapy. When a prescription is received, Customer Success reaches out to them to discuss therapy, answer their questions including costs, and arrange shipment to them.

Once delivered, they meet with your patient by phone or video to setup therapy; approximately 60% of the patients request this personal support. Additionally, there are instructions and videos to get started using Cala Trio. After this initial training, Customer Success continues to support them with Cala Trio including helping them understand how therapy best fits into their life.

In 2021, Cala Trio will add a personalized digital experience to their therapy. It will help patients and their supporting clinicians learn about their use of Cala Trio therapy in managing their hand tremor. If you’re interested in learning about what Cala Trio can share with you about your tremor, contact CustomerSuccess@CalaTrio.com to let us know.

It is recommended that other devices be used in separate sessions since no data has been published using electrical stimulation devices simultaneously with Cala Trio.

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